(53 days)
Not Found
No
The 510(k) summary describes a laparoscopic surgical sleeve for maintaining a port and coagulating tissue, with no mention of AI, ML, image processing, or data-driven performance metrics. The predicate devices are also standard surgical tools.
Yes
The device is intended to "coagulate tissue," which is a therapeutic function.
No
The device is described as an RF Sleeve used during laparoscopic surgery to maintain a port of entry and to coagulate tissue, which are therapeutic and access functions, not diagnostic ones.
No
The device description and performance studies indicate a physical device ("RF Sleeve") used during surgery, not a software-only product.
Based on the provided information, the NTERO RF Sleeve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use during laparoscopic surgery to maintain a port of entry and coagulate tissue. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically on biological samples) diagnostic test.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Lack of IVD Characteristics: The document lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical components or processes associated with IVD devices.
Therefore, the NTERO RF Sleeve is a surgical device used during a procedure, not a diagnostic device used to test samples.
N/A
Intended Use / Indications for Use
The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Not Found
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)
Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
USSC Versaport Sleeve (K954108), Surgical Laser SLT Hemosleeve Bipolar Sheath (K984018), Dorsal Orthopedic Coaqulating Cannula (K953696)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: July 30, 1999
510(k) number: K992572
Applicant Information:
NTERO Surgical, Inc. 1137D San Antonio Rd Palo Alto, CA 94303
| Contact Person: | D. Bommi Bommannan |
|---|---|
| Phone Number: | (650) 428-1000 ext. 101 |
| Fax Number: | (650) 428-0700 |
Device Information:
Classification: Class II Trade Name: NTERO RF Sleeve Classification Name: Electrosurqical Device and accessories (21 CFR 870,4400)
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the USSC Versaport Sleeve (K954108), the Surgical Laser SLT Hemosleeve Bipolar Sheath (K984018) and the Dorsal Orthopedic Coaqulating Cannula (K953696).
Intended Use:
The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coaqulate tissue.
Test Results:
Performance
Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function.
Biocompatibility
The materials used in the NTERO Probe have been shown to be biocompatible.
Summary:
Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. D. Bommi Bommannan President NTERO Surgical, Inc. 1137D San Antonio Road Palo Alto, California 94303
Re: K992572 Trade Name: NTERO RF Sleeve Regulatory Class: II Product Code: GEI Dated: July 30, 1999 Received: August 2, 1999
Dear Mr. Bommannan:
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 Ouality System Regulation (QS) 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. D. Bommi Bommannan
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,
to welle
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
Indications for Use
510(k) Number (if known):
K992572 ---------
Device Name:
NTERO RF Sleeve . . . . . . . . . . . .
Indications for Use:
The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.
・
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992572 |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-the Counter Use |
|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)