(137 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and intended use of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an implant used in plastic and reconstructive surgery for tissue fixation, which falls under cosmetic or reconstructive purposes rather than treating or diagnosing a disease or condition.
No
The device is described as an implant used to fixate subdermal tissue in plastic and reconstructive surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a sterile implant consisting of a polymer strand with steel introducers, indicating it is a physical hardware device, not software.
Based on the provided information, the NUVANCE* Facial Rejuvenation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fixate subdermal tissue in an elevated position in plastic and reconstructive surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "sterile implant" used in "minimally invasive face-lift and facial contouring procedures." This further reinforces its use in a surgical context.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The NUVANCE system does not involve the examination of such specimens.
The NUVANCE system is a surgical implant used in the body, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
Product codes (comma separated list FDA assigned to the subject device)
MXW
Device Description
NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility.
The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead, midface, jowls and neck
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)
Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements
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.
Not Found
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Ko52953 1/2
JMP-2005-014
MAR 6 2006
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Jennifer M. Paine Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West. PO Box 151 Somerville. NJ 08876
Name/Classification of Device:
Class II in 21 CFR § 878.5010, Nonabsorbable polypropylene surgical suture (GAW)
Trade Name:
NUVANCE* Facial Rejuvenation System or NUVANCE For Face
Predicate Devices:
PRONOVA* Suture ENDOTINE Midface Device FEATHERLIFT Threads CONTOUR Threads
Statement of Intended Use:
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
Device Description:
NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility.
The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, barbed implant intended for use in lifting and supporting soft tissue in the face and neck. Like several of the currently marketed devices, the proposed device is made
1
K052955 2/2
JMP-2005-014
of nonabsorbable polymer. The polymer used is identical to that of PRONOVA* suture, currently marketed by Ethicon, Inc.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
- Trademark of Ethicon, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 6 2006
Ethicon, Inc. c/o Ms. Jennifer M. Paine, M.S. Manager, Regulatory Affairs Route 22 West P.O. Box 151
Somerville, New Jersey 08876
Re: K052953
Trade/Device Name: NUVANCE* Facial Rejuvenation System Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: MXW Dated: January 27, 2006 Received: January 30, 2006
Dear Ms. Paine:
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, 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 (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.
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.
3
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/cdrh/industry/support/index.html.
Sincerely yours,
elmee
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KOS2953". The characters are handwritten in a simple, slightly irregular style. The sequence appears to be a code or identifier, possibly a serial number or product code.
JMP-2005-014
Indications for Use
510(k) Number (if known): Ko5295
Device Name: NUVANCE* Facial Rejuvenation System
Indications for Use:
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
*Trademark.
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lmdee
: 15100 SION-1 vision of General, Restorative, ·i Neurological Devices
K052453 Ok) Number_