← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K012150 # PATTON ENDO-BAG (K012150) _Patton Medical Corp. · GCJ · Sep 20, 2001 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K012150 ## Device Facts - **Applicant:** Patton Medical Corp. - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Sep 20, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Patton Endo-Bag™ is a device that is used during laparoscopic procedures to temporarily store and/or remove tissues. ## Device Story Patton Endo-Bag is a single-use retrieval bag for laparoscopic surgery. Device temporarily contains organs or tissues during removal to prevent contamination. Used by surgeons in clinical settings during laparoscopic procedures. Facilitates safe extraction of specimens from the abdominal cavity. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Single-use retrieval bag for laparoscopic specimen containment. Mechanical device; no energy source or software components. ## Regulatory 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 - ENDOPOUCH SPECIMEN RETRIEVAL BAG ([K933104](/device/K933104.md)) - PLEATMAN SAC SPECIMEN CONTAINER ([K923945](/device/K923945.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) Summary as required by 807.92(c) for Patton Endo-Bag™ Prepared July 5, 2001 | Submitted by: | Patton Medical Corporation
1000 Westbank Drive, Suite 5A200
Austin, Texas 78746
512 329-0469 Fax 512 328-9113 | |--------------------|-------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Michael T. Patton
President | | Device Trade Name: | Patton Endo-Bag™ | | Common Name: | Laparoscopic Specimen Retrieval System | | Classification: | Laparoscope, General & Plastic Surgery, § 876.1500, Class II | | Predicate Devices: | ENDOPOUCH SPECIMEN RETRIEVAL BAG (K933104), manufactured by
Ethicon, Inc., P.O. Box 151, Somerville, NJ 08876. | | | PLEATMAN SAC SPECIMEN CONTAINER (K923945) manufactured by Cabot
Medical Corp., 2021 Cabot Blvd. West, Langhorne, PA 19047. | Description of Device: The Patton Endo-Bag™ is a single-use retrieval bag designed to temporarily contain organs or stones, and facilitate their removal from the patient without contamination during laparascopic surgery. Intended Use of Device: The Patton Endo-Bag™ is a device that is used during laparoscopic procedures to temporarily store and/or remove tissues. Substantial Equivalence to Predicate Device: The Patton Endo-Bag™ is substantially equivalent to the Endopouch Specimen Retrieval Bag (K933104), manufactured by Ethicon, Inc., P.O. Box 151, Someville, NJ 08876, and the Pleatman Sac Specimen Container (K923945), manufactured by Cabot Medical Corp., 2021 Cabot Blvd. West, Langhorne, PA 19047. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Public Health Service SEP 2 0 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Michael T. Patton President Patton Medical Corporation 1000 Westbank Drive, Suite 5A200 Austin, Texas 78746 Re: K012150 Trade/Device Name: Patton Endo-Bag Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 5, 2001 Received: July 10, 2001 Dear Mr. Patton: 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. 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. {2}------------------------------------------------ Page 2 – Mr. Michael T. Patton This letter will allow you to begin marketing your device as described in your Section 510(k) I remarket 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Walker, us 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 {3}------------------------------------------------ Page of K012150 510(k) Number (if known): Patton Endo-Bag Device Name: Indications For Use: The Patton Endo-Bag is a single use retrieval bag designed to temporarily contain organs or tissues and facilitates their removal from the patient without contamination, during laparoscopic surgery. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) \$ Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Occaral, RestorativeOver-The-Counter Use and Neurological Devices (Optional Formal 1-2-96) 510(k) Number_KO1Z 150 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K012150](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K012150) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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