K102581 · Byrne Medical, Inc. · ODC · Nov 8, 2010 · Gastroenterology, Urology
Device Facts
Record ID
K102581
Device Name
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Applicant
Byrne Medical, Inc.
Product Code
ODC · Gastroenterology, Urology
Decision Date
Nov 8, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Device Story
The DEFENDO™ Disposable Suction Valve is a single-use, sterile accessory for GI endoscopes. It attaches to the endoscope's suction cylinder port. When the clinician depresses the valve button, it activates the suction function, allowing fluid to flow from the endoscope's distal tip through the valve stem into a suction pump canister. The device is operated manually by a physician or technician during endoscopic procedures. By providing a disposable alternative to reusable valves, it eliminates the need for reprocessing/re-sterilization, potentially reducing cross-contamination risks. The device is designed to be compatible with specific Olympus endoscope series (140/160/180/240/260).
Clinical Evidence
Bench testing only. No clinical data. Testing compared the subject device to the predicate across five parameters: connection ease, priming time, material quantity removed (suction capacity), spring force/displacement, and sharp edge safety. Results showed comparable performance: priming time (3.92s vs 4.16s), suction volume (512.2g vs 528.5g), and spring force/displacement. All tests passed.
Technological Characteristics
Disposable suction valve for GI endoscopes. Mechanical operation via spring-loaded button. Compatible with Olympus 140/160/180/240/260 series endoscopes. Sterile, single-use. No electronic components or software.
Indications for Use
Indicated for use in male and female patients, ranging from pediatric to adult, during GI endoscopic procedures to control suction function on compatible Olympus endoscopes.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. John Willis Director of Regulatory Affairs Byrne Medical Inc. 3150 Pollok Dr. CONROE TX 77303
NOV - 8 2010
Re: K102581
Trade/Device Name: DEFENDO™ Disposable Suction Valve for G1 Endoscopes Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, FDF Dated: September 7, 2010 Received: September 9, 2010
Dear Mr. Willis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
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Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the . quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.him for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hushut Lemur, MD
lerbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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Traditional 510(k) Submission Byrne Medical, Inc., Conroe, Texas 77303
# Indications for Use
510(k) Number (if known)
Device Name: DEFENDO™ Disposable Suction Vaļve for GI Endoscopes
Indications for Use:
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hebert Lemon
Page 1 of 1
sion Sian-Off on of Reproductive. Gastro-Ren 510(k) Number
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# 510(k) Summary of Safety and Effectiveness Data
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# Summary of Safety and Effectiveness Data
The Byrne Medical, Inc., DEFENDO™ Disposable Suction Valve and predicate device (Olympus® MH-443 Suction Valve, K001241) are in Class II, 21 CFR 876.1500 with Advisory Committee of Gastroenterology/Urology.
The predicate device Olympus® - Suction Valve (K001241) is manufactured by Olympus® Optical Co. Ltd. Tokyo, Japan.
The Byrne Medical, Inc., DEFENDO™ Disposable Suction Valve has been determined to meet the equivalence decision making process as detailed by the "510(k) Substantial Equivalence Decision-Making Process Flowchart".
| Characteristic | Byrne Medical | Olympus® | Same? |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Part number | 100305 | MH-443 | N/A |
| Trade Name | 100305 DEFENDO™<br>Disposable Suction Valve | Olympus® EVIS EXERA<br>Colonovideoscopes | N/A |
| 510(k) Doc. Number | This submission | K001241 | N/A |
| Product Code | KOG | FDF | No |
| Regulation Number | 876.1500 | 876.1500 | Yes |
| Class | II | II | Yes |
| Review Advisory<br>Committee | Gastroenterology/Urology | Gastroenterology/Urology | Yes |
| Indications for use | The DEFENDO™ Disposable<br>Suction Valve is intended to<br>be used to control the<br>Suction function on an<br>endoscope during a GI<br>endoscopic procedure. | The Olympus® Suction valve<br>is intended to be used to<br>control the Suction function<br>on an Olympus ®endoscope<br>during a GI endoscopic<br>procedure. | Yes |
| Sterile | Yes | No, user must sterilize | No |
| Single Use | Yes | No, re-sterilize, re-use | No |
| Compatible<br>Endoscope(s) | Olympus®<br>140/160/180/240/260 series<br>endoscopes | Olympus®<br>140/160/180/240/260 series<br>endoscopes | Yes |
| Patient Population | Male/Female, Pediatric to<br>Adult | Male/Female Pediatric to<br>Adult | Yes |
| Reusable or<br>disposable | Disposable | Reusable | No |
### Table 14-1: Comparison of features and principles of operation between the DEFENDO™ Disposable Suction Valve and Predicate Device (Olympus®MH-443 Suction Valve, K001241)
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#### Testing:
The DEFENDO™ Disposable Suction Valve testing was conducted under FDA recognized standards.
#### Similarities and Differences:
#### Indications for Use
Both products are attached to the Suction cylinder of the endoscope. When the valve is depressed, suction function on the endoscope is activated allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.
The DEFENDO™Disposable Suction Valve and its predicate have the same regulation number and class, the same patient population and environment of use.
Neither the predicate nor the Byrne Suction valve come in direct contact with the patient. Fluid flow is one way, away from patient..
#### Comparative Testing
#### Bench testing for the 100305 Suction Valve
#### Background:
Bench testing is performed to confirm that the disposable BMP-215 DEFENDO™ Disposable Suction Valve is equivalent to the predicate Olympus® MH-443 Suction Valve. Accontance criteria.
| Acceptance criteria: | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection to<br>the endoscope | The valve must connect to the endoscope by aligning valve with port<br>and pressing down. Must not be cumbersome to attach. |
| Priming time to<br>Suction<br>Canister | The device must be comparable to the predicate device in terms of<br>being able to supply water within a reasonable time frame (priming<br>time). |
| Material<br>Quantity<br>Removed | The device must be comparable to the predicate device in terms of the<br>amount of water removed in the defined time frame. |
| Spring Force &<br>Displacement | The device must be comparable to the predicate device in terms of<br>force required to activate the button. |
| No sharp<br>edges | The device must not be capable of snagging or piercing a nitrile glove<br>if the wearer rubs his or her gloved fingers over any surface of the<br>device. |
Sq.
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| Materials and Equipment | |
|-------------------------------------|----------------------|
| Olympus® 160 series endoscope | Nitrile Glove |
| Olympus® MH-443 Suction Valve | Stopwatch |
| Byrne Medical BMP-215 Suction Valve | Endo SmartCap |
| IMADA Force Gage | Olympus Suction Pump |
| Water Basin with water | Scale |
| Suction Tube for Suction Pump | |
- 1. To test connection to the endoscope: Aligned BMI suction valve with port and pressed down. Recorded observations on the ease of use as compared to predicate.
- 2. To test for priming time: Test set-up replicated a tvpical Gl system for procedures by attaching the suction valve into the port and using a sterile water bottle with a new SmartCap. Placed the distal tip in a water bath. Turned the suction pump on, set the stop watch to 0. Then depressed the suction button and quantify the time it takes for the water to travel from the distal tip of the endoscope to the suction canister.
- 3. To test for material quantity removed: Drained water from scope and removed water from suction canister, weighed empty canister and zeroed scale, returned canister to suction pump and replaced cap on canister, inserted endoscope into water basin. turned suction pump on, set stop watch to 0, depressed suction valve firmly with finger over the complete button head and held for 30 seconds. At the end of the 30 seconds, removed finger from button, removed canister from suction pump and weighed the amount of net water suctioned through the scope. Determined if the predicate and the disposable have comparable material quantity removal.
- 4. To test for spring force: Attached the suction valve into the port and fixtured the port channel under the IMADA force gage. Used a flat attachment on the force gage to be able to depress the suction valve. Recorded the force/ displacement readings to create a curve.
- 5. To test for sharp edges: Placed nitrile gloves on tester's hand and attached the suction valve to the port. Touched every part of valve, especially the spring area. Recorded observations on snagging or ripping of glove.
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- 6. To test connection to the endoscope: Align BMI suction valve with port notches and press down. Record observations on the ease of use.
- 7. To test for priming time: Test set-up replicated a typical Gl system for procedures by attaching the suction valve into the port and the suction line to the suction pump. Place the distal tip in a water bath. Turn the suction pump on and set the stop watch to 0. Then depress the suction button and quantify the time it takes for the water to travel from the distal tip of the endoscope to the suction canister.
- 8. To test for material quantity removed: Drain water from the scope and remove water from the suction canister, weigh empty canister and zero scale, return canister to suction pump and replace cap on canister, insert endoscope into water basin, turn suction pump on, set stop watch to 0, depress suction valve firmly with finger over the complete button head and hold for 30 seconds. At the end of the 30 seconds, remove finger from button, remove canister from suction pump and weigh the amount of net water suctioned through the scope. Determine if the oredicate and the disposable have comparable material quantity removal.
- To test for spring force and displacement: Attach the suction valve into the port and 9. fixture the endoscope body under the IMADA force gage. Use a flat attachment on the force gage to be able to depress the suction valve. Record the force and displacement readings to compare products.
- 10. To test for sharp edges: Tester is to put on nitrile gloves and attach the suction valve to the port. Ask tester to touch every part of valve, especially the spring area. Record observations on snagging or ripping of glove.
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. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
res
#### Results:
1. Connection to the endoscope
| Olympus (predicate) | BMI 100305 |
|---------------------|------------|
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Smooth | Smooth |
| Average | Average |
| Smooth | Smooth |
#### Result: Pass
The force required to connect the BMI suction valve (100305) and the ease of installation was similar to the predicate (Olympus® MH-443). Alignment with the port notches was comparable. Test results verify that the BMI suction valve (100305) is substantially equivalent to the predicate device.
62
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#### 2. Priming time:
| Olympus (predicate) | BMI 100305 |
|-----------------------|-----------------------|
| 4.19 | 3.97 |
| 4.19 | 3.93 |
| 4.21 | 4.13 |
| 4.32 | 4.09 |
| 4.19 | 4.00 |
| 3.82 | 3.71 |
| 4.21 | 3.59 |
| 4.12 | 3.97 |
| | 3.91 |
| | 3.97 |
| Average | Average |
| 4.16 | 3.92 |
| Standard<br>Deviation | Standard<br>Deviation |
| 0.147 | 0.163 |
#### Result: Pass
The test was performed to establish the time that the water took to travel from the water reservoir to the distal tip of the endoscope. The results indicate that there is no significant difference between the two units. The BMI suction valve is substantially equivalent to the predicate (MH-443).
65
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#### 3. To test for material quantity removed
Eight BMP-215 and eight MH-443 Suction Valves were tested for suction ability by placing an endoscope into a filled water basin. Suction Valves were depressed with finger over hole in valve head and suction was performed for thirty seconds ten times each for each of the eight valves. The results are presented below:
| Olympus MH-443 Suction Valve | | | | | | | | | |
|---------------------------------|------|-------|-------|-------|-------|-------|-------|-------|-------|
| Sample | | | | | | | | | |
| | Test | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| Material<br>Removed<br>In Grams | 1 | 534.4 | 541.2 | 540.0 | 545.4 | 544.5 | 540.8 | 543.3 | 545.7 |
| | 2 | 533.3 | 537.5 | 522.8 | 523.7 | 525.8 | 516.3 | 510.0 | 515.3 |
| | 3 | 539.6 | 552.7 | 531.6 | 522.9 | 521.3 | 513.6 | 509.8 | 513.0 |
| | 4 | 553.1 | 545.1 | 540.0 | 520.5 | 523.2 | 515.1 | 513.3 | 509.6 |
| | 5 | 554.4 | 541.8 | 522.8 | 527.2 | 532.0 | 517.8 | 514.2 | 511.0 |
| | 6 | 556.4 | 539.1 | 531.6 | 524.0 | 529.4 | 516.8 | 511.1 | 512.8 |
| | 7 | 551.1 | 548.0 | 540.0 | 534.7 | 524.2 | 520.0 | 520.6 | 510.1 |
| | 8 | 553.5 | 534.3 | 522.8 | 524.2 | 517.7 | 515.6 | 517.1 | 522.5 |
| | 9 | 550.3 | 544.5 | 531.6 | 529.8 | 507.9 | 527.0 | 520.8 | 529.3 |
| | 10 | 546.8 | 527.9 | 540.0 | 536.5 | 513.2 | 515.4 | 505.7 | 512.4 |
| Average | | 547.3 | 541.2 | 532.3 | 528.9 | 523.9 | 519.8 | 516.6 | 518.2 |
| Grand Average | | | | | | | | 528.5 | |
| Standard Deviation | | | | | | | | 13.61 | |
િત્ર
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## Traditional 510(k) Submission
| Byrne Medical Suction Valve | | | | | | | | | | | | | | | | | |
|---------------------------------|--------|-------|-------|-------|-------|-------|-------|-------|--------------------|--|--|--|--|--|--|--|-------|
| | Sample | | | | | | | | | | | | | | | | |
| | Test | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | | | | | | | | |
| Material<br>Removed<br>in Grams | 1 | 540.5 | 536.9 | 535.7 | 533.2 | 538.8 | 535.8 | 542.0 | 539.5 | | | | | | | | |
| | 2 | 511.6 | 505.4 | 509.8 | 514.9 | 510.9 | 518.5 | 507.7 | 506.2 | | | | | | | | |
| | 3 | 501.6 | 508.2 | 507.8 | 504.8 | 520.3 | 505.5 | 503.1 | 509.2 | | | | | | | | |
| | 4 | 520.4 | 515.4 | 511.2 | 507.1 | 520.3 | 524.9 | 499.6 | 509.3 | | | | | | | | |
| | 5 | 517.4 | 508.0 | 510.0 | 511.4 | 515.9 | 506.0 | 504.2 | 493.4 | | | | | | | | |
| | 6 | 511.1 | 506.8 | 509.5 | 498.7 | 507.0 | 520.2 | 526.4 | 489.9 | | | | | | | | |
| | 7 | 483.9 | 510.2 | 516.2 | 501.6 | 504.4 | 506.9 | 509.1 | 508.6 | | | | | | | | |
| | 8 | 494.6 | 508.7 | 522.4 | 519.9 | 513.3 | 514.6 | 517.4 | 511.3 | | | | | | | | |
| | 9 | 510.0 | 508.3 | 498.0 | 519.6 | 504.0 | 512.2 | 504.9 | 504.2 | | | | | | | | |
| | 10 | 511.6 | 509.9 | 509.6 | 509.1 | 510.2 | 504.7 | 510.8 | 510.4 | | | | | | | | |
| Average | | 510.3 | 511.8 | 513.0 | 512.0 | 514.5 | 514.9 | 512.5 | 508.2 | | | | | | | | |
| Grand Average | | | | | | | | 512.2 | Standard Deviation | | | | | | | | 11.25 |
| Grand Average | | | | | | | | 512.2 | | | | | | | | | |
| Standard Deviation | | | | | | | | 11.25 | | | | | | | | | |
#### Result: Pass
The test was performed to determine the amount of material that can be removed when engaging the device. Looking at the upper and lower limit of delivery (for 30 seconds) vielded a difference of +23g and -8g versus the BMI suction valve. This equates to < 4.5% difference for the worst case view. It should be noted that doctors typically operate suction for only 5-10 seconds at a time. As a result this would further reduce any perceived variation to less than 3.3% difference (528.5/30*10-512.2/30*10=176.2-170.3= 5.9g; 5.9/176.3= 3.3%). The BMI unit additionally shows improved repeatability as compared to the predicate (SD of 11.25 versus 13.61) which will further reduce variability.
{12}------------------------------------------------
#### 4. Spring force and Displacement
| Olympus (predicate) | BMI 100305 | | |
|---------------------|-------------------|--------------------|-------------------|
| Force (lb) | Displacement (in) | Force (lb) | Displacement (in) |
| 2.02 | 0.190 | 2.98 | 0.193 |
| 2.04 | 0.191 | 2.51 | 0.198 |
| 2.16 | 0.188 | 2.86 | 0.200 |
| 2.07 | 0.187 | 2.92 | 0.194 |
| 2.05 | 0.181 | 2.97 | 0.200 |
| 2.21 | 0.186 | 3.02 | 0.199 |
| 1.95 | 0.183 | 2.94 | 0.194 |
| 2.15 | 0.197 | 2.90 | 0.196 |
| | | 2.56 | 0.194 |
| | | 2.96 | |
| Average | | Average | |
| 2.0813 | 0.1876 | 2.862 | 0.1962 |
| Standard Deviation | | Standard Deviation | |
| 0.086 | 0.005 | 0.178 | 0.003 |
#### Result: Pass
The physics formula for the force of the spring is Hooke's Law F=- kx, where F is force, k is spring constant and x is displacement. The spring constants of the predicate and BMI suction valve were determined by using a force gage with a displacement gage. The measured values show a slight difference between the two devices, however, these differences cannot be perceived in blind tests by the tester or other selected parties (3 additional people). The BMI suction valve force and displacement is substantially equivalent to the predicate (MH-443).
{13}------------------------------------------------
#### 5. Sharp edges
| Olympus (predicate) | BMI 100305 |
|---------------------|------------|
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| Pass | Pass |
| | Pass |
| | Pass |
| Average | Average |
| Pass | Pass |
#### Result: Pass
Testing showed that the BMI Suction valve does not pinch, cut, or tear the nitrile gloves. Test results confirm that BMI Suction Valve (100305) effectively attached and removed from corresponding port without posing a pinch, cut, or tear hazard to a healthcare professional's PPE (gloves). The BMI suction valve is substantially equivalent to the predicate (MH-443) for potential for tearing a glove.
#### Conclusion:
Based on these results, we have determined that the Byrne Medical DEFENDO™ Disposable Suction Valve is substantially equivalent to the Olympus MH-443 Suction Valve.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
