K222783 · Lsi Solutions, Inc. · GCJ · Jan 12, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K222783
Device Name
MD Mattress Suture Placement Device
Applicant
Lsi Solutions, Inc.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jan 12, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The MD™ MATTRESS Device is intended for use in the approximation of soft tissue and prosthetic materials.
Device Story
Nonpowered, hand-operated suture placement device; facilitates horizontal mattress stitches. Input: manual lever actuation by physician. Mechanism: lever-driven system advances dual curved needles across tissue jaw to engage needle caps with pre-loaded suture; retraction pulls suture through tissue. Features: angulation knob (up to 15°), rotational knob (6 positions), jaw width indicator, and needle axle indicator. Used in surgical environments (open or minimally invasive/cannula-based). Output: placed suture stitches. Benefits: enables precise, repeatable suture placement for soft tissue/prosthetic approximation.
Clinical Evidence
No clinical data. Bench testing only. Verification and validation testing confirmed design inputs met. Biocompatibility testing per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity). Packaging/shelf-life testing per ISO 11607-1:2019 demonstrated 2-year shelf life.
Technological Characteristics
Nonpowered, hand-operated; stainless steel and polymer construction. Conforms to ISO 10993-1:2018. Features: dual curved needles, angulation/rotational knobs. Sterilization: ethylene oxide (minimum lethality 10^-6). Single-patient-use.
Indications for Use
Indicated for use in the approximation of soft tissue and prosthetic materials in patients requiring such procedures.
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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January 12, 2024
LSI Solutions, Inc. Christopher Miller Executive Director of Regulatory Affairs and Quality 7796 Victor-Mendon Rd Victor, New York 14564
Re: K222783
Trade/Device Name: MD Mattress Suture Placement Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Codes: GCJ, GAS Dated: June 21, 2023 Received: June 22, 2023
Dear Christopher Miller:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely, Tek N. v signed by Tek N Lamichhane -S Date: 2024.01.12 17:17:45 -05'00 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known) K222783
Device Name MD™ MATTRESS Suture Placement Device
Indications for Use (Describe)
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitted By: | LSI SOLUTIONS, Inc.<br>7796 Victor-Mendon Road<br>Victor, NY 14564 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher B. Miller<br>Executive Director of Regulatory Affairs and Quality<br>Phone: (585) 869-6665<br>Fax: (585) 742-8086<br>Email: cmiller@lsisolutions.com |
| Date Prepared: | 10 JAN 2024 |
| Trade Name: | MD™ MATTRESS Suture Placement Device |
| Common Name: | Needle Guide |
| Classification Name: | Endoscope and Accessories (per 21 CFR 876.1500) |
| Classification Regulation: | 21 CFR 876.1500 |
| Product Code: | GCJ (Primary Product Code)<br>GAS (Secondary Product Code) |
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#### Device Classification: Class II
Predicate Device:
RD180® - THE RUNNING DEVICE® (Cleared under Premarket Notification K100593)
#### Device Description
The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with
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attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.
While the MD™ MATTRESS Device is used for the placement of MD™ QUICK LOAD® SURGICAL SUTURES, this premarket submission does not include a request for clearance of suture materials since MD™ QUICK LOAD® SURGICAL SUTURE is listed on FDA's Establishment Registration and Device Listing database (K203081).
One (1) MD™ MATTRESS Device is provided per package, and the MD™ MATTRESS Device is intended to facilitate the placement of multiple sutures through tissue and prosthetic materials.
#### Intended Use
The MD™ MATTRESS Device is intended for use in the approximation of soft tissue and prosthetic materials.
#### Indications for Use
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
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#### Technological characteristics (comparison to Predicate Device)
Both the predicate RD180® Device and the subject MD™ MATTRESS Device have the same intended use: "Intended for use in the approximation of soft tissue and prosthetic materials." The predicate RD180® Device is "indicated for use in the approximation of soft tissue and prosthetic materials," and LSI recommends its use with 2-0 polyester suture, among other suture types. The subject MD™ MATTRESS Device has similar indications. The MD™ MATTRESS Device is "indicated for use in the approximation of soft tissue and prosthetic materials." The subject and predicate devices are both designed for sewing suture on similar technical principles. Both devices are single-patient-use, nonpowered, hand-operated devices that incorporate a leverdriven mechanism that pierces needles through tissue, picks up suture, and pulls the suture back through the tissue to facilitate placing a stitch.
Both the subject and predicate devices operate on the same principle to accomplish the tasks the devices are intended to perform. These tasks include: loading suture needle caps into the device tip; passing the device tip through the surgical access site (optionally through a cannula if appropriate); selecting the desired device tip position over a target site; firing needles through tissue and pulling the suture back through the tissue; rearming the device to allow for placement of additional tissue bites (as deemed appropriate by the surgeon); and removing the suture needle caps from the needles. Both the subject and predicate devices are provided sterile, after sterilization with ethylene oxide such that a minimum lethality of 10% is achieved. The predicate RD180® Device is a stainless steel and polymer suture delivery device. The MD™ MATTRESS Device is made from similar, often identical, materials. Both devices conform to the requirements of ISO 10993. The predicate device is packaged in a rigid thermoformed PETG
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blister tray with a Tyvek® cover. The subject device is packaged in the similar configuration with similar materials: a blue-tint PETG tray and retainer inserted into a Tyvek®/Nylon pouch.
The MD™ MATTRESS Device and the predicate RD180® Device are substantially equivalent. The subject and predicate devices are comparable, and the differences do not introduce any new risks, and have no negative impact on the safety and efficacy of the MD™ MATTRESS Device.
A summary of the comparison between the subject MD™ MATTRESS Device and predicate RD180® Device is provided in the table below.
| Table 6: Substantial Equivalence Comparison | | |
|---------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Subject Area | Predicate Device:<br>RD180® - THE RUNNING<br>DEVICE® | Subject Device:<br>MD™ MATTRESS Device |
| 510(k) Number: | K100593 | K222783 |
| Device Class: | II | II |
| Classification<br>Regulation: | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code: | GCJ | GCJ |
| Intended Use: | Intended for use in the<br>approximation of soft tissue and<br>prosthetic materials. | Intended for use in the<br>approximation of soft tissue and<br>prosthetic materials. |
| Indications for Use: | Indicated for use in the<br>approximation of soft tissue and<br>prosthetic materials. | Indicated for use in the<br>approximation of soft tissue and<br>prosthetic materials. |
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| Table 6: Substantial Equivalence Comparison | | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Area | Predicate Device:<br>RD180® - THE RUNNING<br>DEVICE® | Subject Device:<br>MD™ MATTRESS Device |
| Single Use/<br>Reusable: | Single Use | Single Use |
| Design: | Device tip (including a tissue<br>jaw, single straight needle, and a<br>needle cap compartment) | Device tip (including a tissue<br>jaw, jaw width indicator, dual<br>curved needles, needle axle<br>indicator, needle cap<br>compartments, and an<br>angulation indicator) |
| | Device shaft | Device shaft (including an<br>angulation knob, rotational knob<br>with an integrated eyelet and<br>indicator fin) |
| | Pink lever | Lavender lever |
| | White handle | White handle |
| Table 6: Substantial Equivalence Comparison | | |
| Subject Area | Predicate Device:<br>RD180® - THE RUNNING<br>DEVICE® | Subject Device:<br>MD™ MATTRESS Device |
| Technological<br>Characteristics: | Nonpowered, hand-operated; incorporating a lever-driven<br>mechanism utilizing needle-and-<br>needle-cap technology to place<br>suture through tissue or<br>prosthetic materials using a<br>single straight needle.<br><br>The predicate device does not<br>contain any articulation or<br>rotational knobs or functions. | Nonpowered, hand-operated; incorporating a lever-driven<br>mechanism utilizing needle-and-<br>needle-cap technology to place<br>suture through tissue or<br>prosthetic materials using dual<br>curved needles.<br><br><span style="vertical-align:middle">COMPARABLE</span><br><br>The subject device contains an<br>articulation knob, which can be<br>used to angulate the device tip<br>inward or outward, and a<br>rotational knob, which enables<br>the device shaft and<br>correspondingly the device tip<br>to rotate through six distinct<br>positions. |
| Target Population: | Any patient requiring the<br>approximation of soft tissue or<br>prosthetic materials. | Any patient requiring the<br>approximation of soft tissue or<br>prosthetic materials.<br><br><span style="vertical-align:middle">SAME</span> |
| Table 6: Substantial Equivalence Comparison | | |
| Subject Area | Predicate Device:<br>RD180® - THE RUNNING<br>DEVICE® | Subject Device:<br>MD™ MATTRESS Device |
| Environment of<br>Use: | Suitable for use in any<br>environment where surgical<br>procedures occur under the<br>supervision of a physician.<br><br>Compatible with open surgeries,<br>smaller access/minimally<br>invasive surgeries, and surgery<br>through a cannula or other<br>access ports with seals to<br>maintain positive CO2 pressure<br>at the surgical site. | Suitable for use in any<br>environment where surgical<br>procedures occur under the<br>supervision of a physician.<br><br>Compatible with open surgeries,<br>smaller access/minimally<br>invasive surgeries, and surgery<br>through a cannula or other<br>access ports with seals to<br>maintain positive CO2 pressure<br>at the surgical site. |
| Sterility | To be sterilized with ethylene<br>oxide such that a minimum<br>lethality of 10-6 is achieved. | To be sterilized with ethylene<br>oxide such that a minimum<br>lethality of 10-6 is achieved. |
| Materials and<br>Biocompatibility | Comprising stainless steel and<br>polymers.<br>Conforms to the requirements of<br>ISO 10993-1:2009. | Comprising stainless steel and<br>polymers.<br>Conforms to the requirements of<br>ISO 10993-1:2018. |
| Packaging | Packaged in a rigid<br>thermoformed PETG tray with a<br>Tyvek® cover. | Packaged in a PETG tray and<br>retainer lid which are sealed in a<br>Tyvek®/Nylon pouch. |
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# Performance Testing Summary
Bench top performance testing was conducted to verify that the MD™ MATTRESS Device will perform as intended and to ensure the device will perform equivalently to the predicate device.
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The following non-clinical tests were conducted, and all results met the performance and riskbased acceptance criteria:
- . Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met.
- Biocompatibility per ISO 10993-1:2018 and in accordance with FDA Guidance for . Industry Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, September 4, 2020. The MD™ MATTRESS Device can be classified as an externally communicating medical device that has limited contact (≤24 hours) with tissue. The battery of testing included:
- Chemical characterization O
- Cytotoxicity o
- Sensitization O
- Irritation o
- Material-mediated pyrogenicity o
- 0 Acute systemic toxicity
- . Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life.
## Clinical Testing
Not applicable. Neither the predicate nor the subject product require clinical testing. The substantial performance testing discussed above confirms the reliability and excellent performance of the MD™ MATTRESS Device. The performance testing included multiple experiments that do not require clinical testing in patients.
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## Substantial Equivalence
The subject device and predicate device have the same intended use and technological characteristics. Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device.
### Conclusion
The subject MD™ MATTRESS Device is substantially equivalent to the predicate RD180® Device, submitted under Premarket Notification K100593 and cleared in 2010. Extensive testing demonstrates that the proposed product consistently provides excellent suture placement and can be dependably manufactured. The MD™ MATTRESS Device will be safe and effective for the approximation of soft tissue and prosthetic materials.
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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.
