(23 days)
Not Found
No
The device description and intended use describe a mechanical surgical port and sleeve, with no mention of software, algorithms, or any capabilities that would suggest AI/ML is involved.
No
The device is indicated for establishing a port of entry for endoscopic instruments, which is a surgical access function, not a therapeutic treatment.
No
The device is described as an obturator and sleeve used to establish a port of entry for endoscopic instruments in surgical procedures. Its intended use is to facilitate access for other instruments, not to diagnose conditions. Performance studies focus on its ability to create this port, not on diagnostic accuracy.
No
The device description clearly outlines physical components (obturator, sleeve) and their materials and sizes, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to establish a port of entry for endoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a physical instrument (obturator and sleeve) designed for surgical access, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Auto Suture* Soft Thoracoport* obturator and sleeve is a surgical device, not an IVD.
N/A
Intended Use / 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.
Product codes
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Auto Suture* Soft Thoracoport** Obturator and Sleeve
IX. 510(k)_Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical
150 Glover Avenue
Norwalk, 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 Trocar
and Sleeve (K903419)Endopath Disposable Flexible Surgical
Cannula (K931111) |
| DEVICE DESCRIPTION: | 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. |
| INTENDED 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. |
| MATERIALS: | All component materials of the Auto Suture* Soft
Thoracoport** obturator and sleeve are comprised of materials
which are in accordance with ISO Standard # 10993-1. |
| PERFORMANCE DATA: | 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. |
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 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.
2
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
3
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