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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than "prove" performance against acceptance criteria in the manner of a novel device study. Therefore, the questions related to AI studies, multi-reader multi-case studies, and ground truth for training sets are not applicable here.

Here's an analysis based on the provided text, focusing on how the device demonstrates equivalency rather than meeting specific performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K033842 Nubert, and relevant safety and performance standards. The "reported device performance" for the Mediflex 24003-MF is its characteristic comparison to the predicate.

CHARACTERISTICS	Mediflex 24003-MF (Reported Device Performance)	Acceptance Criteria (Predicate Device K033842 Nubert and Standards)	Met/Not Applicable
Sterility Method	ISO11135-1 EO method (SAL: 10-6)	Radiation process (SAL: 10-6)	Met (Equivalent SAL)
Sterile Bag Material	PU coated on nylon polyamide	PU coated on nylon polyamide	Met
Size (Area Dimension)	195mm x 90mm	195mm x 90mm	Met
Open/Close Method	Instruction (1 page)	Instruction (2 pages)	Met (Identical procedure)
Disposal	One (1) time use	One (1) time use	Met
Function	Collection, extraction of tissue via 10mm, 11mm or 12mm cannula	Collection, extraction of tissue via 10mm, 11mm or 12mm cannula	Met
Biocompatibility	ISO10993-1	ISO10993-1	Met
Durability/Life	ISO11607 / 5 year shelf (with Tyvek Peel Pouch)	ISO11607 / 5 year shelf	Met
Body Contact Type/Duration	Tissue, Blood / < 24 hr	Tissue, Blood / < 24 hr	Met
Quality System	ISO9001/GMP/ISO13485 Certified	Implied bypredicate being marketed (expected equivalent QMS)	Met (Certified)
Risk Management	ISO14971-1:2007 Compliant	Implied by predicate being marketed (expected equivalent risk management)	Met (Compliant)
Packaging Sterilization	EN868-5 Annex D Sealing Strength, ASTM F1929-98 Dye Penetration Test, etc.	Implied by predicate being marketed (equivalent protective packaging)	Met (Validated)

Explanation of "Met" for Sterile Method: While the methods differ (EO vs. Radiation), both achieve the same Sterility Assurance Level (SAL: 10-6), demonstrating functional equivalence for the purpose of sterilization. The submission explicitly states "Sterilization by means of EO by the contract sterilizer assures a sterility assurance level of 10-6."

2. Sample Size for Test Set and Data Provenance

This submission is a 510(k) for substantial equivalence, not a clinical study in the typical sense with a "test set" of patient data. The "tests" performed are bench tests and validations against recognized standards. Therefore, there is no sample size of patient data or data provenance from countries. Instead, tests were conducted on the device components and final product. Specific sample sizes for each bench test (e.g., sterilization validation, biocompatibility) are not detailed in this summary but would be part of the full submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not a study requiring expert ground truth for interpretation of clinical data or images. The "ground truth" for this substantial equivalence is the established performance and safety of the predicate device and compliance with universally recognized standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical data or imaging interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically related to diagnostic devices, particularly those involving human interpretation, sometimes aided by AI. This device is a surgical tool, and such a study is not relevant to its substantial equivalence determination.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

No. This device is a physical surgical tool and does not involve AI algorithms or human-in-the-loop performance in the sense of software-driven decision making.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

Predicate Device Characteristics: The known design, materials, function, and performance parameters of the legally marketed predicate device (Vernon-Carus Limited, K033842 Nubert).
Recognized Standards: Compliance with international and national standards for medical device safety, material biocompatibility, sterilization, packaging, and quality systems (e.g., ISO10993-1, ISO11135-1, ISO11607, ISO14971-1). These standards themselves represent a consensus "ground truth" for aspects like sterility assurance levels, biocompatibility, and risk management.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm or AI model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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:

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 CORPd/b/a MEDIFLEX 24003-MF	VERNON-CARUS LIMITEDK033842 NUBERT
STERILE	ISO11135-1 EO method(SAL: 10-6)	Radiation process(SAL: 10-6)
SIZE	Area dimension 195mm x 90mm(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	Instruction1 page Section 13	Instruction2 pages Section 12
DISPOSAL	One ( 1 ) time use	One ( 1 ) time use
FUNCTION	Collection, extraction of tissue via10mm, 11mm or 12mm cannula	Collection, extraction of tissue via10mm, 11mm or 12mm cannula
BIOCOMPATIBILITY	ISO10993-1	ISO10993-1
DURABILITY/LIFE	ISO11607 / 5 year shelfTyvek Peel Pouch	ISO11607 / 5 year shelf
BODY CONTACTTYPE/DURATION	Tissue, Blood / < 24 hr	Tissue, Blood / < 24 hr

COMPARISON TO PREDICATE DEVICE:

INDICATIONS AND INTENDED USE:

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

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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

INDICATIONS FOR USE

510(K) Number (if known):

Device Name:

Laparoscopic Tissue Retrieval Bag model 24003-MF

Indications for Use:

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

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(Division Sign-off) Division of Surgical Devices 510(k) Number: K123728

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.