The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
Device Story
Laparoscopic tissue retrieval bag (Model 24003-MF) used for collecting and extracting tissue during laparoscopic surgery; single-use, disposable, sterile pouch; constructed of polyurethane-coated polyamide; inserted through 10mm, 11mm, or 12mm cannulas; operated by surgeons; provides a receptacle for tissue containment during extraction; facilitates safe removal of tissue specimens from the abdominal cavity; minimizes risk of tissue contamination during retrieval.
Clinical Evidence
Bench testing only. No clinical data. Compliance verified via ISO 10993 (biocompatibility, sensitization, irritation, cytotoxicity, hemolysis, systemic toxicity, pyrogenicity), ISO 11135-1 (sterilization), ISO 11607-2 (sealing/aging), and ASTM F1929-98 (dye penetration).
Technological Characteristics
Materials: Polyurethane-coated nylon polyamide. Dimensions: 195mm x 90mm. Sterilization: Ethylene Oxide (EO) per ISO 11135-1 (SAL 10^-6). Packaging: Tyvek peel pouch. Single-use, disposable. Biocompatibility: ISO 10993-1 compliant.
Indications for Use
Indicated for use as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures via 10mm, 11mm, or 12mm cannulas.
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.
Predicate Devices
Vernon-Carus Limited, Nubert, Albert, and Hubert (K033842)
Submission Summary (Full Text)
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## 510(K) SUMMARY - K123728 August 29, 2012
DEC 1 1 2013
#### SUBMITTER INFORMATION: (2424366)
Flexbar Machine Corp. (d/b/a Mediflex) 250 Gibbs Road Islandia. New York 11749 Tel: 631-582-8440 Contact: Mr. Larry Derrig
## FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:
North American Technical Services (NATS) Corp. 30 Northport Rd Sound Beach, NY 11789 Tel: 631-744-0059 Fax: 631-744-0192 Email: natscorp@aol.com Contact: Stephen T. Mlcoch
#### DEVICE NAME:
Name: Laparoscopic Tissue Retrieval Bag, Model 24003-MF Proprietary Model: 24003-MF Classification: Il Product Code: GCJ Regulation: 21 CFR 876.1500
#### PREDICATE DEVICES:
#### Vernon-Carus Limited, K033842 Models Nubert, Albert, and Hubert
#### DESCRIPTION:
The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.
#### SUBSTANCIAL EQUIVALENCE AND TECHNOLOGY:
The Mediflex laparoscopic tissue retrieval bag model 24003-MF is substantially equivalent in design, construction and materials to the identified predicate device model Nubert. They both use the same technology, function the same way and have the identical purpose. They both are the same size and open or close in an identical procedure. There is a Tyvek peel pouch that contains the coated paper over the sterile pouch bag made of polyurethane (PU) coating over nylon polyamide.
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The difference to the predicate device is the material source vendor used for the sterile pouch bag but not the material type. Both use the same generic polyurethane (PU) coating over nylon polyamide for the sterile pouch bag. The sterilization methods differ too. EO method is used for 24003-MF and a radiation process is used for predicate model Nubert.
Sterilization by means of EO by the contract sterilizer assures a sterility assurance level of 100 . The biocompatibility evaluation has shown compliance to ISO10993-1 for the predicate device Nubert and 24003-MF. The specific test evaluations assure material source differences are compliant. Therefore, this device is as safe. It is as effective and performs equivalent to the predicate device by sustaining the same construction. The use of Tyvek peel pouch as a container for the sterile tissue pouch assures a durable and equivalent method to the validated predicate device bag container.
| CHARACTERISTICS | FLEXBAR MACHINE CORP<br>d/b/a MEDIFLEX 24003-MF | VERNON-CARUS LIMITED<br>K033842 NUBERT |
|-------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| STERILE | ISO11135-1 EO method<br>(SAL: 10-6) | Radiation process<br>(SAL: 10-6) |
| SIZE | Area dimension 195mm x 90mm<br>(see drawing Section 11) | Area dimension 195mm x 90mm |
| STERILE BAG MATERIAL | PU coated on nylon polyamide | PU coated on nylon polyamide |
| OPEN / CLOSE METHOD | Instruction<br>1 page Section 13 | Instruction<br>2 pages Section 12 |
| DISPOSAL | One ( 1 ) time use | One ( 1 ) time use |
| FUNCTION | Collection, extraction of tissue via<br>10mm, 11mm or 12mm cannula | Collection, extraction of tissue via<br>10mm, 11mm or 12mm cannula |
| BIOCOMPATIBILITY | ISO10993-1 | ISO10993-1 |
| DURABILITY/LIFE | ISO11607 / 5 year shelf<br>Tyvek Peel Pouch | ISO11607 / 5 year shelf |
| BODY CONTACT<br>TYPE/DURATION | Tissue, Blood / < 24 hr | Tissue, Blood / < 24 hr |
## COMPARISON TO PREDICATE DEVICE:
## INDICATIONS AND INTENDED USE:
The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
## SUMMARY OF NONCLINICAL TESTS AND DESIGN CONTROL ACTIVITIES:
The performance and safety bench testing activities were conducted on the tissue retrieval bag to establish the safety compliance is sustained for the new device. Validation and verification of compliance with the following mandatory and voluntary standards has been made to validate new production process using new vendor sources are compliant.
- · 1SO9001/GMP/ISO13485: Quality System Certification
- · ISO14971-1:2007 Risk Management
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- · ISO10993-1:2009 Biocompatibility
- · ISO10993-10:1995 Sensitization Test
- · ISO10993-10:1995 Irritation / Intracutaneous Reactivity Test
- · ISO10993-5:1999 Memelution Cell Culture Cytotoxicity Test
- · ISO10993-4:2002 Hemolysis Test
- · ISO10993-11:2006 Systemic Toxicity Test
- · ISO10993-11:2006 Pyrogenicity Test
- · ISO11135-1:2007 Sterilization Validation
- · ISO11607-2:2009 Sealing and Accelerated Aging
- · ISO11737-1:2006 Bioburden Test
- · EN868-5 Annex D Sealing Strength
- · ASTM F1929-98 Dye Penetration Test
- · EN868-5 Annex E Pealing Characteristic
- · EN868-5 Annex B Resistance of Sterilization
Factory and contract vendor locations are qualified. A registered contract sterilizer and quality system certification for the contract factory exists to support Flexbar Machine Corp., manufacturing requirements. The risk analysis shows that there are no new questions of safety and effectiveness for the Mediflex laparoscopic tissue retrieval bag model 24003-MF.
#### CONCLUSION:
The Mediflex laparoscopic tissue retrieval bag model 24003-MF is substantially equivalent to the predicate device identified. It is suitable for the same use and functions according to equivalent device instructions. The same construction, function, technology exist with equivalent materials. The material source differences are validated by new tests. Differences in sterility methods and containment bag have been validated. There is controlled production activity, test validation history to recognized Standards and production verification procedures in place. No new safety issues are evident and the test evaluation compliance demonstrates the device is as safe, effective and performs as well as the predicate device. Substantial equivalence is evident.
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Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is a stylized emblem featuring a symbol that resembles a caduceus or a staff with intertwined snakes. The emblem is black and stands out against the white background of the seal.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
Flexbar Machine Corporation (d/b/a Mediflex) c/o Stephen T. Mlcoch North American Technical Services (NATS) Corp. 30 Northport Road Sound Beach, New York 11789
December 11, 2013
Re: K123728
Trade/Device Name: Laparoscopic Tissue Retrieval Bag, Model 24003-MF Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 26, 2013 Received: November 13, 2013
Dear Mr. Micoch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be 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 commore to they 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. Too may, therefore, manisions of the Act include requirements for annual registration, listing of I he general ochilibition 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{4}------------------------------------------------
Page 2 - Stephen T. Micoch
forth in the quality systems (QS) 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.htm 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Joshua C. Nipper -S
Binita Ashar, MD, MBA, FACS Acting Director For
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# K123728
K123728
## INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Laparoscopic Tissue Retrieval Bag model 24003-MF
Indications for Use:
The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
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)
Long H. Chen -A
pic, cm.Long H. Chen -
300.100.1.1 =] 300368056
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for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K123728
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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.
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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.
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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.
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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.
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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.
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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.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
