(60 days)
The Contour Forehead/Browlift Thread™ is indicated for use in browplasty surgery. The Contour Forehead/ Browlift Thread™ is indicated for use to fixate the subdermis to the periosteum of the Cranium in browplasty.
The Contour Forehead/Browlift Threads™ are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture material. The 20 centimeter length incorporates a unidirectional-cogged section 10 centimeters long from the distal end. The 12 centimeter length incorporates a bi-directional design from the center. Both Unidirectional and Bidirectional Threads will have a 4 inch needle attached to the distal ends, with a 26 mm curved needle attached to the proximal end of the Unidirectional Thread and a 1 1/2 inch straight needle attached to the proximal end of the Bidirectional Threads. The threads are supplied sterile for single use.
The provided text is a 510(k) summary for a medical device called "Contour Forehead/Browlift Threads™". This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a report detailing acceptance criteria and performance from an independent study.
Therefore, the following information about acceptance criteria and study details cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a study
- Sample size for the training set
- How the ground truth for the training set was established
What can be extracted from the document:
The document primarily focuses on establishing "substantial equivalence" of the "Contour Forehead/Browlift Threads™" to existing, legally marketed predicate devices. This involves demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Key statements related to "performance" and "evaluation" are:
- "Bench and animal evaluations have demonstrated the device to be safe and effective."
- "It is equivalent to other 510 (k) approved surgical sutures and identical to Surgical Specialties' Polypropylene Surgical Sutures, PMA 870064."
This implies that standard biocompatibility and performance testing (likely mechanical strength, material integrity, etc., typical for sutures) was conducted, and the results were found to be comparable to the predicate devices. However, specific numerical acceptance criteria or performance metrics are not detailed in this summary. The FDA's letter states that they reviewed the submission and found the device "substantially equivalent."
{0}------------------------------------------------
page 1/2
DEC - 3 2004
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter: | Surgical Specialties Corporation |
|---|---|
| Address: | 100 Dennis DriveReading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth LazaroRegulatory Affairs Specialist |
| Date Prepared: | October 14, 2004 |
| Name of Device: | Contour Forehead/Browlift Threads™ |
| Common / Usual | GAW |
| Classification Name: | Suture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Coapt Endotine Forehead Device K014153Featherlift Extended Length Thread (ContourThreads™) K041593 |
| Indications For Use: | The Contour Forehead/Browlift Thread™ isindicated for use in browplasty surgery. TheContour Forehead/ Browlift Thread™ is indicatedfor use to fixate the subdermis to the periosteum ofthe Cranium in browplasty. |
{1}------------------------------------------------
.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Device Description | The Contour Forehead/Browlift Threads™ are a clear,nonabsorbable, sterile, surgical strand of polypropylene.The base product is USP size 2-0 polypropylene suturematerial. The 20 centimeter length incorporates aunidirectional-cogged section 10 centimeters long fromthe distal end. The 12 centimeter length incorporates abi-directional design from the center. BothUnidirectional and Bidirectional Threads will have a 4inch needle attached to the distal ends, with a 26 mmcurved needle attached to the proximal end of theUnidirectional Thread and a 1 1/2 inch straight needleattached to the proximal end of the BidirectionalThreads. The threads are supplied sterile for single use. |
|---|---|
| Technological Characteristics: | The Polypropylene material used for the ContourForehead/Browlift Threads™ is commonly used inmedical applications and has been proven to bebiocompatible. Bench and animal evaluations havedemonstrated the device to be safe and effective. Itis equivalent to other 510 (k) approved surgicalsutures and identical to Surgical Specialties'Polypropylene Surgical Sutures, PMA 870064. |
| Substantial Equivalence | The Contour Forehead/ Browlift Thread™ isidentical in the intended use to the predicateEndotine Forehead device.The Contour Forehead/Browlift Thread™ uses thesame suture material as the predicate FeatherliftExtended Length Thread (Contour Threads™). Theapproved suture material is Polypropylene. TheContour Forehead/Browlift Threads™ intended useis in browplasty surgery to fixate the subdermis tothe periosteum of the cranium in browplasty. |
The Contour Forehead/ Browlift Threads™ Surgical Specialties Corporation
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K042856
K042830
Trade/Device Name: Contour Forehead / Browlift Threads™ Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical structure
Regulation Name: Nonabsorbable polypropylene surgical structure Regulatory Class: II Product Code: GAW Dated: October 14, 2004 Received: October 15, 2004
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regary manced provided Device Americans, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacultere with the provisions of the Federal Food, Drug, devices that have been reculted in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general positions of You may, therefore, market the device, seejoer of the since in the many of mightending and general controls provisions of the Act networks and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) in existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA m may be subject to such additional controller Linking in Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Code of I ouch Ingening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a backen a requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmanon that young administered by other Federal agencies. You must or any Federal Statures and regulations daministered of not limited to: registration and listing (21 l comply with an the Act s requirements, merceans, were and actually and as set CFR Part 807), labeling (21 CFRT art 820); good and if applicable, the electronic forth in the quality systems (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" (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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K042656
Indications for Use
510(k) Number (if known): K042856
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Contour Forehead / Browlift Thread™ is indicated for use in browplasty surgery.
The Contour Forehead / Browlift Thread™ is specifically indicated for use to fixate the subdermis to the periosteum of the Cranium in browplasty.
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Koy 2856
§ 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.