LINA-BAG, MODELS LB-60, LB-100

K030422 · Lina Medical Cml Aps · GCJ · Apr 14, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030422
• Device Name: LINA-BAG, MODELS LB-60, LB-100
• Applicant: Lina Medical Cml Aps
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The LiNA-Bag is a sterile, single-use bag designed to contain tissue, small organic matter temporarily in order to facilitate the removal of this matter without wound contamination during laparoscopic procedures.

Device Story

LiNA-Bag is a sterile, single-use laparoscopic specimen retrieval device. It consists of a collapsible pouch attached to a long, slender, multi-part tube. The device is introduced into the patient through a laparoscopic trocar. The surgeon operates the device manually using a push-pull motion on the tube, which activates an attached nylon drawstring to open or close the pouch. The pouch contains tissue or organic matter during extraction to prevent wound contamination. It is used by surgeons in clinical laparoscopic settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laparoscopic specimen retrieval device; consists of a collapsible pouch and a multi-part tube with a nylon drawstring mechanism. Manual operation via push-pull motion. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for use in laparoscopic surgery to temporarily contain and facilitate removal of organs, stones, or tissue structures, including appendix, ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, and small sections of bowel, without wound contamination.

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

• Patton Endo-bag (K0122150)
• ENDOPOUCH Specimen Retrieval Bag (K933104)
• Auto Suture ENDO CATCH Single Use Specimen Pouch (K922123)

Submission Summary (Full Text)

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K030422

APR 1 4 2003

# 510(K) Summary as required by 21 CFR section 807.92 for LiNA-BAG Prepared February 7, 2003

| Submitted by: | LiNA Medical CML ApS<br>Formervangen 5<br>Glostrup<br>Denmark DK-2600 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Device Trade Name:<br>Common Name:<br>Classification: | Mr. Niels Kornerup, President<br>LiNA-Bag<br>Laparoscopic Specimen Retrieval Device<br>Laparoscopic, General & Plastic Surgery, 876.1500 Class II |
| Predicate Devices: | Patton Endo-bag (K0122150), distributed by Patton Medical,<br>1000 Westbank Drive, Suite 5A200, Austin, TX 78746<br>ENDOPOUCH Specimen Retrieval Bag (K933104), manufactured by Ethicon,<br>Inc., P.O. Box 151, Somerville, NJ 08876<br>Auto Suture ENDO CATCH Single Use Specimen Pouch<br>(K922123), manufactured by U.S. Surgical, Division of TYCO, 150 Glover Ave.,<br>Norwalk, CT 06856 |

### Description of Device:

The LiNA-Bag is a laparoscopic instrument consisting of a collapsible pouch attached and placed within a long slender multi-part tube allowing for introduction of said pouch through a laparoscopic trocar. Opening and closing of the pouch is activated by manual manipulation in a push and pull motion of the attached tube that has a corresponding nylon drawstring attached to the pouch.

### Intended Use of Device:

The LiNA-Bag is a sterile, single-use bag designed to contain tissue, small organic matter temporarily in order to facilitate the removal of this matter without wound contamination during laparoscopic procedures.

### Substantial Equivalence to Predicate Device:

The LiNA-Bag is substantially equivalent to the Patton Endo-bag (K0122150), distributed by Patton Medical, 1000 Westback Drive, Suite 5A200, Austin, TX 78746 and the ENDOPOUCH Specimen Retrieval Bag (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876 and the Auto Suture ENDO CATCH Single Use Specimen Pouch (K922123), manufactured by U.S. Surgical, Division of TYCO, 150 Glover Ave, Norwalk, CT 06856.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Mr. Niels Kornerup President LiNa Medical CML ApS Formervangen 5 Glostrup, Denmark DK-2600

Re: K030422

Trade/Device Name: LiNa-Bag Regulation Number: 21 CFR 876.1500 Regulation Names: Endoscope and accessories Regulatory Class: II Product Codes: GCJ Dated: February 7, 2003 Received: February 10, 2003

Dear Mr. Kornerup:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Niels Kornerup

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark N Millkern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NR. 999 S. 3

Indications for Use

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510(k) Number (if known): K030422

LiNA-Bag, model LB-60 & LB-100 Device Name:

Indications for Use:

A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark R. Milleson
(Division Sign-Off)

Restorative Divis anc

510(k) Number K030926

http://www.fda.gov/cdrh/ode/indicate.html

21-03-03