(23 days)
The Auto Suture* Soft Thoracoport* obturator and sleeve is indicated for use in establishing a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required.
The Auto Suture* Soft Thoracoport** obturator and sleeve consists of a sterile, single-use, blunt-tipped obturator and a flexible threaded sleeve. The threaded sleeve has a shroud at its proximal end to protect against foreign materials entering the cavity and for instrument stabilization. The Auto Suture* Soft Thoracoport** obturator and sleeve is available in 5mm, 12mm and 15mm sizes.
The provided text describes the "Auto Suture* Soft Thoracoport** Obturator and Sleeve" device and its 510(k) summary, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/ML performance evaluation.
The document states:
- "Pre-clinical laboratory evaluations were performed to ensure that the device could be used as designed."
- "The studies demonstrated substantial equivalence to the predicate device in creating a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required."
This indicates that the evaluations were done to show substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. This is a different type of evaluation than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) for an AI/ML model and then conducting a study to demonstrate those criteria were met.
Therefore, I cannot fill out the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory approval based on pre-clinical evaluations and substantial equivalence to existing devices, not on the performance metrics typically associated with AI/ML systems.
Here's why I cannot provide the requested information from the given text:
- Nature of the Device: The device is a surgical instrument (obturator and sleeve), not an AI/ML diagnostic or predictive system. Therefore, the concept of "acceptance criteria" for a fixed performance metric (like accuracy for an AI system) doesn't directly apply in the same way. The "performance data" section refers to pre-clinical evaluations ensuring it can be used as designed and is substantially equivalent to predicate devices.
- Lack of Specific Performance Metrics: The text does not list any quantitative performance metrics (e.g., sensitivity, specificity, AUC, F1-score) that would constitute "acceptance criteria" for an AI model.
- No AI/ML Study Details: The document does not describe any study involving AI, machine learning, human readers, or ground truth establishment in the context of an algorithm's performance.
If this were an AI/ML device, the detailed information requested would typically be found in a dedicated "Clinical Study Report" or "Performance Study" section of the 510(k) submission, clearly defining the study design, endpoints, and results. The provided text is a summary of safety and effectiveness, focused on the regulatory pathway of substantial equivalence.
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Auto Suture* Soft Thoracoport** Obturator and Sleeve
IX. 510(k)_Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical150 Glover AvenueNorwalk, CT 06856 |
|---|---|
| CONTACT PERSON: | Christopher A. Graham |
| DATE PREPARED: | July 2, 1999 |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery |
| COMMON NAME: | Blunt-Tipped Obturator and Cannula |
| PROPRIETARY NAME: | Auto Suture* Soft Thoracoport** obturator and sleeve |
| PREDICATE DEVICES: | Auto Suture* Modified Surgiport* Disposable Surgical Trocarand Sleeve (K903419)Endopath Disposable Flexible SurgicalCannula (K931111) |
| DEVICE DESCRIPTION: | The Auto Suture* Soft Thoracoport** obturator and sleeveconsists of a sterile, single-use, blunt-tipped obturator and aflexible threaded sleeve. The threaded sleeve has a shroud atits proximal end to protect against foreign materials enteringthe cavity and for instrument stabilization. The Auto Suture*Soft Thoracoport** obturator and sleeve is available in 5mm,12mm and 15mm sizes. |
| INTENDED USE: | The Auto Suture* Soft Thoracoport** obturator and sleeve isindicated for use in establishing a port of entry for endoscopicinstruments (straight and curved) in thoracic and otherprocedures, where insufflation is not required. |
| MATERIALS: | All component materials of the Auto Suture* SoftThoracoport** obturator and sleeve are comprised of materialswhich are in accordance with ISO Standard # 10993-1. |
| PERFORMANCE DATA: | Pre-clinical laboratory evaluations were performed to ensurethat the device could be used as designed. The studiesdemonstrated substantial equivalence to the predicate device increating a port of entry for endoscopic instruments (straight andcurved) in thoracic and other procedures, where insufflation isnot required. |
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Christopher A. Graham Senior Associate, Regulatory Affairs Tyco International (US), Inc. United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K992288
Trade Name: Auto Suture* Soft Thoracoport Obturator and Sleeve Regulatory Class: II Product Code: GCJ Dated: July 2, 1999 Received: July 7, 1999
Dear Mr. Graham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Christopher A. Graham
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Indications For Use:
510(k) Number (if known):
Name: Auto Suture* Soft Thoracoport** obturator and sleeve
Indications For Use:
The Auto Suture* Soft Thoracoport* obturator and sleeve is indicated for use in establishing a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use: X OR Over-The-Counter Use:
(Per 21 CFR §801.109)
(Division Sign-Off)
Devices C
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K
510(k) Premarket Notification
United States Surgical *Trademark of United States Surgical **Trademark name not yet determined
§ 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.