TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021

K092821 · Agency For Medical Innovations, Inc. · GCJ · Feb 1, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092821
• Device Name: TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
• Applicant: Agency For Medical Innovations, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The "TissueBags" are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during surgical procedures.

Device Story

TissueBag system serves as a receptacle for specimen collection and removal during minimally invasive surgery. Device consists of a bag, suspension mechanism, protection sleeve, and handle (integrated or via A.M.I.-dock applicator). Surgeon positions bag near target tissue; bag opens automatically for specimen loading. Closure achieved by pulling back the device or an integrated purse string. Used in clinical settings by surgeons. Disposable, single-use, sterile device designed for 10 mm ports. Facilitates safe tissue extraction, reducing risk of contamination or tissue loss during retrieval.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, functional principle, and material biocompatibility testing (ISO 10993-1).

Technological Characteristics

Disposable, single-use specimen retrieval bag. Components: bag, suspension mechanism, protection sleeve, handle. Materials: Tyvek and PET-foil packaging. Sterilization: Radiation (SAL 10^-6). Compatible with 10 mm surgical ports. Mechanical operation via manual purse-string or device retraction.

Indications for Use

Indicated for the collection and removal of surgical specimens including appendix, gallbladder, myoma, cysts, ovaries, fibroid tumors, and calculi during minimally invasive surgical 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.

Predicate Devices

• Autosuture Endoscopic Specimen Pouch (K922123)

Submission Summary (Full Text)

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FEB - 1 2010

## 5. 510(k) Summary

510(k) number:

510(k) submitter (owner):

A.M.I. Inc. -20 Main Street Suite 205 Natick MA 01760

official contact person authorized by the submitter: Andrew Bendheim A.M.I. Inc. 20 Main Street Suite 205 Natick MA 01760 U.S.A. Phone: [phone]

Date of preparation:

1. September 2009

Name of the device:

- trade or proprietary name: common or usual name: classification name:
A.M.I. TissueBag System TissueBag Endoscope and accessories (21 CFR 876.1500, Product Code GCJ)

Predicate Devices used for Substantial Equivalence:

K 922123 / Autosuture Endoscopic Specimen Pouch / Specimen Retrieval Device

#### Device description:

The TissueBags are intended as receptacles for safe collection and removal of specimen during surgical procedures. Removal is accomplished by positioning the bag that serves as a receptacle for the specimen, close to the specimen that is intended to be removed. The bag opens, and the feeding-mouth is kept open automatically. Closure of the filled bag is done either by pulling back the complete device, or by pulling back an integrated purse string only.

The TissueBags comprise various types of retrieval bags, which share similarities of the basic functional principle, materials, Sterile-Barrier-Packaging, delivery status and sterilisation method. The TissueBags differ in the size of their bag (loading capacity), the availability of an integrated handle, respectively the need for being connected to an A.M.I.-dock Applicator pre-operatively and the possibility to disconnect the filled bag from the instrument.

Each TissueBag consists of a bag, a suspension mechanism, a protection sleeve and a handle, that is either an integrated part of the device or attached in terms of an A.M.I.dock Applicator. One type of the TissueBags is additionally equipped with a purse string.

510(k) TissueBag

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k092821

All TissueBags are designed to be applicable with 10 mm ports for minimally invasive surgery. They are disposable, delivered sterile as single use devices. Their Sterile-Barrier-Packaging consists of two independently sealed pouches made from Tyvek and PET-foil. Sterilisation by means of Radiation guarantees a Sterility Assurance Level of 10° Biocompatibility evaluation has shown the TissueBags to meet the requirements of ISO 10993-1.

Comparison to predicate device (marketed device of similar type):

The TissueBag is substantially equivalent to the predicate device (marketed device of similar type) in design, basic functional principle, principle of operation and clinical effectiveness. The TissueBags provoke no new safety or effectiveness issues when used as intended.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, which is a common emblem associated with health and medical services.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Agency for Medical Innovations. Inc. % Mr. Andrew Bendheim CEO 20 Main Street, Suite 205 Natick, Massachusetts 01760

FEB - 1 2010

Re: K092821

Trade/Device Name: A.M.I. TissueBag System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 22, 2010 Received: January 27, 2010

Dear Mr. Bendheim:

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

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Page 2 - Mr. Andrew Bendheim

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 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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.


Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

510(k) Number (if known):

K092821

TissueBag

Device Name:

Indications for Use:

The "TissueBags" are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Orf) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number k69284

510(k) TissueBag