The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.

The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

Device Description

The Applied Medical Tissue Containment System is a flexible tissue bag that includes an attached tether and guard accessory. The subject system is provided sterile. The Tissue Containment System is used to contain and isolate specimens for surgical removal and/or manual morcellation. After the device is fully inserted into the abdominal or pelvic cavity, the mouth of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether is used to maneuver the ring to the surface of the extraction site. If the specimen requires manual morcellation, the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site. The guard is placed in the bag opening prior to manual morcellation, providing a robust barrier between the bag and sharp instruments.

AI/ML Overview

The FDA 510(k) summary for the Applied Medical Tissue Containment System (K142427) provides information about its performance testing. However, it does not include specific acceptance criteria or detailed results in a tabular format as you've requested for direct comparison.

Instead, the document states that "Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates... and that the subject device performs comparably to the current marketed device for the same intended use." This indicates that the device met the performance expectations derived from its predicate devices and relevant standards, but the exact quantitative thresholds are not provided in this public summary.

Based on the provided text, here's what can be extracted and inferred regarding your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria or reported performance values. It generally states that "All materials were found to be biocompatible" and that "bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation." and "Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent..."

General interpretation of implicit acceptance criteria based on testing categories:

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	All materials were found to be biocompatible.
Functional Performance	Demonstrated substantial equivalence to predicate devices.
Bag Seam Integrity	Performed comparably to predicate.
Tether Break Force	Performed comparably to predicate.
Puncture Resistance	Performed comparably to predicate.
Dye Penetration	Successfully demonstrated device functionality.
Viral Penetration	Successfully demonstrated device functionality.
Bubble Leak	Successfully demonstrated device functionality.
Simulated Use	Successfully demonstrated device functionality.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for any of the tests conducted (biocompatibility or mechanical). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a medical device for tissue containment, not an AI or diagnostic device that relies on expert interpretation for ground truth establishment. The testing described (biocompatibility and mechanical) uses objective physical measurements and standardized protocols, not human expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of testing conducted. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the case here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done. This device is a physical tissue containment system, not an AI or imaging device, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable for a physical medical device. "Standalone" performance refers to algorithm performance, which is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical and biocompatibility testing is based on:

Standardized laboratory methods and established criteria for biocompatibility: Referring to ISO 10993-1, this involves objective measures for cytotoxicity, irritation, and sensitization.
Physical performance metrics and comparison to predicate devices: For mechanical tests, the ground truth is the measurable physical properties of the device (e.g., actual break force, absence of leakage, resistance to puncture) and its ability to perform its intended function in simulated use, as well as its comparability to the performance of predicate devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI or statistical modeling device.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2014

Applied Medical Resources Corporation Ms. Aeree Lee Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K142427

Trade/Device Name: Applied Medical Tissue Containment System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 21, 2014 Received: November 24, 2014

Dear Ms. Lee:

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, 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.

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K142427

Device Name

Applied Medical Tissue Containment System

Indications for Use (Describe)

The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

Contraindications:

The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.

The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the physician, use of such a device would be contrary to the best interest of the patient.

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

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(K) Submitter:	Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000
Contact Person:	Aeree LeeRegulatory Affairs SpecialistApplied Medical Resourcesaelee@appliedmedical.comTel: (949) 713-8272Fax: (949) 713-8205
Date of Preparation:	August 28, 2014
Trade Name:	Applied Medical Tissue Containment System
Common Name:	Tissue Bag
Classification:	Accessory to Endoscope, Class IIProduct Code: GCJ	Regulation: 21 CFR 876.1500
Predicate Device:	Applied Medical Specimen Retrieval System510(k)#: K060051Product Code: GCJ	Regulation: 21 CFR 876.1500
	Cook LapSac Tissue Entrapment Pouch510(k)#: K910914Product Code: KGY	Regulation: 21 CFR 878.4100
Device Description:	The Applied Medical Tissue Containment System is a flexibletissue bag that includes an attached tether and guard accessory.The subject system is provided sterile.The Tissue Containment System is used to contain and isolatespecimens for surgical removal and/or manual morcellation.After the device is fully inserted into the abdominal or pelviccavity, the mouth of the bag returns to its original, circular shape,facilitating placement of the specimen in the bag. When thespecimen is ready for removal and/or manual morcellation, thetether is used to maneuver the ring to the surface of the
	If the specimen requires manual morcellation, the ring may berepeatedly flipped to shorten the bag and consequently bring thespecimen closer to the extraction site. The guard is placed in thebag opening prior to manual morcellation, providing a robustbarrier between the bag and sharp instruments.
Intended Use:	The Applied Medical Tissue Containment System is indicated tocontain and isolate tissue during, or prior to, surgical removaland/or extracorporeal manual morcellation.
	The Tissue Containment System is contraindicated for laparoscopicpower morcellation during gynecologic procedures.
	The Tissue Containment System is contraindicated for use withpowered cutting devices (e.g., power morcellators, electrosurgicaland laser instruments), and when, in the judgment of the physician,use of such a device would be contrary to the best interest of thepatient.

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extraction site.

Comparison of Technological Characteristics with the Predicate Device:

The subject and predicate devices are both tissue bags intended to retrieve and contain specimens during manual morcellation. Both devices are wholly inserted into the abdominal or pelvic cavity prior to specimen placement in the bag. If the specimen requires morcellation, both bags are brought up to the extraction site prior to morcellation.

The following technological differences exist between the subject and predicate devices:

Mechanism of the bag opening
o Use of different materials
0 Addition of a guard in subject device

Discussion of Performance Testing:

The following performance data is provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the Applied Medical Tissue Containment System was conducted in accordance with the FDA G95-1 Blue Book Memo, the FDA Draft Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''', and the International Standard ISO 10993-1. The subject

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device is a device that contacts tissue for a duration of less than 24 hours and the following tests were considered:

Cytotoxicity
Irritation ●
o Sensitization

All materials were found to be biocompatible.

Mechanical Testing

Side-by-side bench top testing was performed with the subject and predicate devices to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation. Both subject and predicate devices were evaluated for:

Bag seam integrity
o Tether break force
o Puncture resistance

Additional testing was performed on the subject device to evaluate the device functionality:

Dye penetration
Viral penetration
Bubble leak ●
o Simulated use

Conclusions:

Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates Applied Medical Specimen Retrieval System and Cook LapSac Tissue Entrapment Pouch, and that the subject device performs comparably to the current marketed device for the same intended use.

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.