(79 days)
The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.
The device consists of an introducer and a polyurethane specimen container into which the excised gallbladder is placed. The device, with the specimen held within, is then withdrawn through the abdominal access wound (previously created by the trocar). The device can operate through a variety of access port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
The provided text describes the 510(k) summary for the Surgicon, Inc. DeGall Laparoscopic Gallbladder Extractor. However, it does not provide specific details about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study methodologies that would be typically found in a study report. The text focuses on the regulatory submission process and the intended use of the device.
Therefore, for most of your requested information, I must report that the data is not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| General requirement Ability to withdraw and contain specimens under conditions in excess of normal clinical use | "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to withdraw and contain specimens under conditions in excess of those encountered during normal clinical use." (No specific metrics or pass/fail criteria are provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not available. The document states "in-vitro and in-vivo testing" but does not specify sample sizes for these tests.
- Data Provenance: Not available (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not available. This device is a surgical tool, not an AI or diagnostic device requiring expert interpretation for ground truth. The testing mentioned would likely involve engineering and clinical performance evaluations, not expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable/Not available.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not available.
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
- MRMC Study: No. This device is a physical surgical instrument, not an AI or imaging device that would typically be evaluated in an MRMC study related to human reader performance.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a manually powered and controlled physical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the context of typical AI/diagnostic device evaluation. For a surgical device, "ground truth" would refer to its functional performance (e.g., successful specimen containment, integrity of the device, ease of use, safety in animal/cadaver models, etc.), measured through physical tests and observations. The document vaguely mentions "in-vitro and in-vivo testing," implying such functional evaluations.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
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AUG 1 5 2002
SURGICON, INC. E : 099 No Tiploa non
K021747 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Surgicon, Inc.400 Long Beach Blvd. - Stratford, CT 06615 |
|---|---|
| CONTACT PERSON | Curt Raymond |
| DATE PREPARED | May 21, 2002 |
| CLASSIFICATION | Accessory to laparoscope |
| COMMON NAME | Laparoscopic specimen container |
| PROPRIETARY NAME | DeGall Laparoscopic Gallbladder Extractor |
| PREDICATE DEVICES | Auto Suture Endo Catch Specimen PouchMinogue Xtractor Specimen Retrieval |
| DEVICEDESCRIPTION | The device consists of an introducer and a polyurethanespecimen container into which the excised gallbladder isplaced. The device, with the specimen held within, is thenwithdrawn through the abdominal access wound (previouslycreated by the trocar). The device can operate through avariety of access port sizes down to 5mm. The device ismanually powered and controlled. It is composed ofbiologically safe materials. It is supplied sterile and intendedfor single use only. |
| INTENDED USE | The subject device is intended for the retrieval and removalof the gallbladder in laparoscopic cholecystectomies. |
| TESTING | The device has been subjected to in-vitro and in-vivo testingwhich demonstrate the ability of the device to withdraw andcontain specimens under conditions in excess of thoseencountered during normal clinical use. |
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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 features a stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2002
Surgicon, Inc. Curtis Raymond Director, Regulatory & Quality 400 Long Beach Boulevard Stratford, Connecticut 06615
Re: K021747
Trade/Device Name: DeGall Laparoscopic Gallbladder Extractor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCI Dated: May 24, 2002 Received: May 28, 2002
Dear Mr. Raymond:
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. Curtis Raymond
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 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" (21 CFR 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,
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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SURGICON. INC. 5 100K) Notification
KO21747 STATEMENT FOR INDICATIONS FOR USE
The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.
Styd Purcle
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number__KO ² 1747
§ 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.