(77 days)
The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.
The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.
This document, K010620, is a 510(k) summary for the Salute staple removal instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving those criteria are met.
Here's why and what information is available:
- No Acceptance Criteria or Performance Data: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by comparing technical aspects and intended use. It does not present specific quantitative acceptance criteria (e.g., a specific success rate or precision/recall metric) or the results of a study designed to meet such criteria. It's likely that performance was demonstrated through bench testing and a comparison to the predicate device, rather than a formal clinical trial with defined acceptance criteria for a new AI/software device.
- Device Type: This device is an "Endoscopic Staple Removal Instrument," which is a physical, reusable surgical instrument, not an AI or software-based diagnostic device. Therefore, many of your questions, such as those related to AI algorithm performance (standalone, MRMC, training sets, ground truth for AI), are not applicable to this physical medical device.
Let's break down what can be answered based on the provided text, and why other questions cannot be:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or provide a table of reported device performance against such criteria. The basis for clearance is "substantial equivalence" to a predicate device, meaning its safety and effectiveness are considered comparable based on its design and intended use, not necessarily by meeting pre-defined quantitative performance metrics in a clinical trial.
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/Not provided. As a physical instrument, a "test set" in the context of AI data is not relevant. The document does not describe any formal clinical or pre-clinical studies with a "sample size" in the way an AI/software device would have. Testing would typically involve bench testing (e.g., staple removal efficacy, durability, sterilization effectiveness) rather than a data-based test set from patients.
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/Not provided. This question relates to establishing ground truth for AI models, which is not relevant for this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This question is for AI/software device performance evaluation.
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/Not provided. This question is for AI/software device performance evaluation. The device is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This question is for AI/software device performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. This question is for AI/software device performance evaluation.
8. The sample size for the training set
- Not applicable/Not provided. This question is for AI/software device development.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This question is for AI/software device development.
In summary: The provided 510(k) summary for the "Endoscopic Staple Removal Instrument" is for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar design, materials (implicitly), and intended use. The questions you've asked are largely tailored to the evaluation of AI or software-as-a-medical-device (SaMD), which operates on a different regulatory and evaluative framework.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Onux Medical, Inc. Mr. John Rice Vice President of Engineering 5 Merrill Drive Hampton, NH 03842
JUL 2 7 2015
Re: K010620 Trade/Device Name: Endoscopic Staple Removal Instrument Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated (Date on orig SE Itr): February 27, 2001 Received (Date on orig SE Itr): March 1, 2001
Dear Mr. Rice,
This letter corrects our substantially equivalent letter of May 17, 2001.
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
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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); 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
INDICATIONS
The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.
R. Mark N. Mellema
Division Sign Off
(Division Sign-Off) Division of General, Restorative and New of General, Resto
510(k) Number_________________________________________________________________________________________________________________________________________________________________ KO10620
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510(k) Summary
2/27/2001
Onux Medical, Inc., Contact Person: Trade or Proprietary Name: Common or Usual Name: Classification Name:
AY 1 7 2001
John Rice None established Endoscopic staple removal instrument Endoscope and/or Accessory
Devices to Which Equivalence is Claimed
The Salute staple removal instrument is substantially equivalent to the Ethicon Endopath™ ES Endoscopic Staple Extractor.
Description of Subject Device
The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.
Intended Use of Subject Device
Both the Salute staple removal instrument and the Ethicon Endopath ES Endoscopic Staple Extractor are intended for laparoscopic or open removal of staples.
Comparison of Technical Aspects
Both the Salute staple removal instrument and the Endopath ES Staple Extractor are manual re-useable instruments for removing staples in either an open or laparoscopic surgical setting. They both engage the underside of the staple at the distal end of the device shaft. Both have levers that actuate of the staple. While the lever is kept closed, the extracted staple is held by the device for removal to outside the surgical area. Releasing the lever expels the staple from the device shaft.
§ 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.