(279 days)
Not Found
Not Found
No
The summary describes a mechanical device (jaw inserts for a surgical clamp) and makes no mention of AI, ML, image processing, or any data-driven functionalities.
No.
The device is used to temporarily occlude a blood vessel during surgery, which is a surgical tool function, not for treating a disease or condition.
No
Explanation: The device, ENGAGE Jaw Inserts, is used with a surgical clamp to temporarily occlude blood vessels during vascular surgery. Its function is to manipulate tissue (clamp blood vessels) rather than to acquire, process, or analyze data for diagnostic purposes.
No
The device description clearly states "ENGAGE Jaw Inserts are used with a surgical clamp" and describes them as physical inserts that adapt to a surgical clamp. This indicates a hardware component, not a software-only 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 "occlude a blood vessel temporarily and may be used to clamp over indwelling catheters." This is a direct surgical intervention on the patient's body.
- Device Description: The description reinforces its use with a surgical clamp for temporary occlusion of blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases, conditions, or states of health.
This device is a surgical accessory used during a procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
For Vascular Work
- Suitable for veins and arteries
- ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
- ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.
Product codes
DXC
Device Description
Novare Surgical intends to introduce into commercial distribution the ENGAGE Inserts. The common name for Novare's device is: Surgical Clamp / atraumatic insert. ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery. The principle of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessel, veins and arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
vascular surgery
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)
Not Found
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.
Allegiance Healthcare's Fogarty® Hydragrip® Surgical Clamp (preamendment) and Baxter International's Safejaw Inserts
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
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
JUN - 8 2000
Attachment 2
510(k) SUMMARY
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 8807.92.
Novare Surgical intends to introduce into commercial distribution the ENGAGE Inserts. The equivalent predicate devices are Allegiance Healthcare's Fogarty® Hydragrip® Surgical Clamp (preamendment) and Baxter International's Safejaw Inserts (see copy of Product Insert Sheet in Attachment 2).
The FDA has classified vascular clamps as Class II devices (21CFR870-4450). Novare ENGAGE Inserts are a Class II medical device. The common name for Novare's device is: Surgical Clamp / atraumatic insert.
ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery. The ENGAGE Inserts and Safejaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines.
The principle of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels. The need for clamping is present in most vascular procedures. The device labeling supports the use of these devices for vascular applications in surgery.
T.R. Hoff 12/17/93
Kermit R. Pope, Jr. President/CEO
Date
Novare Surgical 10231 Bubb Road Cupertino, CA 95014 (408) 873-3161
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 8 2000
Mr. Terry Buelna Vice President, Chief Technical Officer Novare Surgical Systems 10231 Bubb Road Cupertino, CA 95014
K992980 Re: Engage Jaw Inserts Trade Name: Requlatory Class: II (two) Product Code: DXC Dated: May 15, 2000 Received: May 17, 2000
Dear Mr. Buelna:
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 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). 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 requirements, as set forth in the Quality 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. Terry Buelna
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) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Brim E. Hawaym
James E. Dillard III
Director
for
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 3
510 (k) Number: K992980
Device Name: ENGAGE Jaw Inserts
Indications For Use
For Vascular Work
- Suitable for veins and arteries
- ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters.
- ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps. .
Sam E. Dunaway
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
OR
Over-The-Counter Use