(60 days)
Not Found
No
The device description and intended use clearly describe a physical surgical thread and its application, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is described as a surgical strand used for fixation in browplasty surgery, which is a structural rather than a therapeutic use.
No
The device is described as a surgical implant (suture material) used for browplasty, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a surgical strand of polypropylene with attached needles, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a surgical thread made of polypropylene, intended for use in browplasty surgery to fixate tissue within the body. It is a physical implant used during a surgical procedure.
The information provided describes a surgical device used in vivo (within the living body), not a device used in vitro (outside the living body) to analyze specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium
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)
Bench and animal evaluations have demonstrated the device to be safe and effective.
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
§ 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.
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page 1/2
DEC - 3 2004
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter: | Surgical Specialties Corporation |
|---|---|
| Address: | 100 Dennis Drive |
| Reading, PA 19606 | |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro |
| Regulatory 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 K014153 |
| Featherlift Extended Length Thread (Contour | |
| Threads™) K041593 | |
| Indications For Use: | 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. |
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 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. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polypropylene material used for the Contour
Forehead/Browlift Threads™ is commonly used in
medical applications and has been proven to be
biocompatible. 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. |
| Substantial Equivalence | The Contour Forehead/ Browlift Thread™ is
identical in the intended use to the predicate
Endotine Forehead device.
The Contour Forehead/Browlift Thread™ uses the
same suture material as the predicate Featherlift
Extended Length Thread (Contour Threads™). The
approved suture material is Polypropylene. The
Contour Forehead/Browlift Threads™ intended use
is in browplasty surgery to fixate the subdermis to
the 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