(14 days)
Not Found
No
The summary describes a mechanical device with no mention of software, algorithms, or data processing that would indicate AI/ML. The changes are related to materials, shape, and manufacturing.
No
The device is described as an "Anastomosis Assist Device" and acts as a "partial occluding clamp" during surgery to assist in creating anastomoses, rather than directly treating a medical condition itself. Its function is to facilitate a surgical procedure, not to provide therapy.
No
The device is described as an "Anastomosis Assist Device" used to "assist in the creation of one to three proximal anastomosis sites" during CABG procedures. Its function is to hold vessels during surgery, not to diagnose a medical condition.
No
The device description explicitly states it is an "intraoperative device" made of "plastic" and includes a "fiber reinforced polymer hex driver," indicating it is a physical hardware device used during surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use by cardiac surgeons during coronary artery bypass grafting (CABG) procedures. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a surgical assist device used intraoperatively. This further confirms its use within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is a surgical tool used inside the body during a procedure.
N/A
Intended Use / Indications for Use
The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant.
The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired. The current FDA cleared indications granted for single and up to three anastomosis procedures remains unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aortas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac surgeons
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.
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
§ 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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'KO32589'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is clear and legible, with a consistent stroke weight.
| Summary of Safety Information
Premarket Notification, Section 510(k) | | NOVARE SURGICAL SYSTEMS, INC.
AUGUST 16, 2003 |
|-------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | |
| Device Name: | ENclose™ II Anastomosis Assist Device | |
| Common Name(s): | Vascular Clamp | |
| Classification Name(s): | Vascular Clamp | |
| Manufacturer: | | |
| Name: | Novare Surgical Systems, Inc. | |
| Reg. Number: | 2954739 | |
| Address: | 10231 Bubb Road
Cupertino, CA 95014 | |
| Classification(s): | | |
| | | Sec. 870.4450 Vascular clamp. (a) Identification. A vascular clamp is a surgical instrument used to occlude a blood |
Class II for the requested indications Device Class: Cardiovascular Devices Panel Classification Panel: Product Code(s): DXC
vessel temporarily. (b) Classification. Class II (performance standards).
Equivalent Predicate Device:
The ENclose™ Anastomosis Assist Device is substantially equivalent to the following legally marketed vascular clamp(s):
Includer™ Vascular Clamp - Novare Surgical Systems, Inc., K010694 Includer™ (ENclose™) Vascular Clamp - Novare Surgical Systems, Inc., K023682
Sec. 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).
Device Class: Class II Product Code(s): DXC
The new anastomosis device is essentially identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testification, surgical technique and indications for use. A feature comparison chart follows this section.
| FEATURE | ENclose™ II Anastomosis Assist Device | Includer™ / ENclose™ | SE? |
|---|---|---|---|
| Indications for | |||
| Use: | The ENclose™ II Anastomosis Assist Device is intended | ||
| for use by cardiac surgeons in place of partial occluding | |||
| clamps during coronary artery bypass grafting (CABG) | |||
| procedures requiring one to three proximal anastomoses | |||
| in ascending aortas free of atheromatous disease. | Identical | YES | |
| Materials: | Medical grade plastic, stainless steel and silicone | Identical | YES |
| Design: | Clamp | Identical | YES |
| Sterilization: | Radiation (e-beam) | Identical | YES |
| Manufacturer: | Novare Surgical Systems, Inc. | Identical | YES |
| Product Code: | DXC | Identical | YES |
| K - Number: | Pending | K010694, K023682 | YES |
1
The proposed changes do not represent a significant or deleterious change to the device. Substantial equivalence is based on all physical and clinical attributes of the device being indistinguishable from the cleared device, including, place of manufacture, physical appearance, though slightly different in color and size, has not affected the performance requirements, functional elements, material certification, surgical technique nor indications for use.
Device Description:
General description of the change(s). The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired. The current FDA cleared indications granted for single and up to three anastomosis procedures remains unchanged.
The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant.
Company Contact:
Mr. Kerry Pope Novare Surgical Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 408.873.3161
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
Special Controls:
FDA published special controls. The following special controls are believed to apply to the marketing of class II devices:
- Compliance with material standards, (i)
- Compliance with biocompatability standard, and (ii)
- (iii) Compliance with specified labeling requirements.
Novare Surgical Systems, Inc. also meets appropriate general controls authorized under Sections 501, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
Sterility Processing:
The ENclose™ II Anastomosis Assist Device is provided sterile and is designed strictly for single patient use. The device may not be cleaned, reprocessed or reused under any circumstances. The product must be handled, stored and placed into use in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following accepted surgical sterile technique.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2003
Novare Surgical Systems, Inc. c/o David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, CA 94523
Re: K032589
Enclose II Anastomosis Assist Device Regulation Number: 21 CFR 870.4450 Regulation Name: Regulatory Class: Class II Product Code: DXC Dated: August 16, 2003 Received: August 22, 2003
Dear Mr. Schlerf:
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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. David Schlerf
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Odel Tule
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K032589
ENclose™ II Anastomosis Assist Device Device Name(s):
Indications for Use Statement(s):
The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Deaton
sion of Cardiovascular Devices
510(k) Number K032589
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
ENCLOSESPECIAL2.DOC