(72 days)
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.
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.
The provided text describes a 510(k) submission for the "Patton Endo-Bag™," a laparoscopic specimen retrieval system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with specific performance thresholds that a device must meet through a new study.
Therefore, the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, and ground truth establishment is not applicable to this 510(k) summary. The approval is based on demonstrating that the new device has the same intended use and similar technological characteristics to previously approved devices, without raising new questions of safety or effectiveness.
Here's how to interpret the provided document in the context of your request:
1. Table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) summary does not describe specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or report performance data against such criteria. The "performance" demonstrated is substantial equivalence to the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or data from a study demonstrating performance against acceptance criteria is described in this 510(k) summary. The submission focuses on comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No experts or ground truth establishment for a test set are mentioned, as there is no performance study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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:
- Not Applicable. This device is a physical medical device (specimen retrieval bag), not an AI imaging or diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No performance study with ground truth data is described.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth establishment is relevant to this device.
Summary of the 510(k) for Patton Endo-Bag™:
The submission demonstrates substantial equivalence to predicate devices (ENDOPOUCH SPECIMEN RETRIEVAL BAG and PLEATMAN SAC SPECIMEN CONTAINER) by highlighting that the Patton Endo-Bag™ shares the same:
- Intended Use: Temporarily contain organs or stones to facilitate removal during laparoscopic surgery without contamination.
- Technological Characteristics: Implied to be similar by the substantial equivalence claim, although specific technical details for comparison are not provided in this summary.
The FDA's letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its marketing subject to general controls. No new clinical or performance studies with acceptance criteria were required for this type of submission.
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510(k) Summary as required by 807.92(c) for Patton Endo-Bag™ Prepared July 5, 2001
| Submitted by: | Patton Medical Corporation1000 Westbank Drive, Suite 5A200Austin, Texas 78746512 329-0469 Fax 512 328-9113 |
|---|---|
| Contact Person: | Michael T. PattonPresident |
| 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 byEthicon, Inc., P.O. Box 151, Somerville, NJ 08876. |
| PLEATMAN SAC SPECIMEN CONTAINER (K923945) manufactured by CabotMedical 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.
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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.
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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
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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.
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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
§ 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.