(98 days)
PMA 870064, K904906
No
The device description and performance studies focus on the physical properties and surgical application of a thread and needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "Featherlift Aptos Extended Length Threads" used in "midface suspension surgery to fixate the cheek subdermis in an elevated position," which directly implies a therapeutic function by physically altering and supporting tissue for a medical purpose.
No
The device is described as surgical threads used for midface suspension surgery, which is a therapeutic intervention, not a diagnostic process.
No
The device description clearly outlines physical components (threads, needle, introducer) made of materials like polypropylene and stainless steel, indicating it is a physical medical device, not software-only.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Featherlift Aptos Extended Length Threads are a surgical implant used in midface suspension surgery to fixate tissue. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen outside the body.
The information provided about the device's materials, intended use, and performance studies all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
The threads are a blue, nonabsorbable, sterile, surgical strand of polypropylene. The product is USP size 2-0 polypropylene suture material 25 centimeters in length and incorporates a unidirectional-cogged section 10 centimeters long from the distal end. A 2 ¾ straight taper cutting needle made of 400 series stainless steel will be swedged to the proximal end. An introducer made of 18 gauge stainless steel will be included for placement of the Threads. The threads and the introducer 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
midface
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)
Physical testing was conducted on the thread to USP 27 for tensile strength, force required to remove after implantation and Biocompatability for permanent implantation, ISO 10993.
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.
PMA 870064, K904906
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
SEP 2 0 2004
K041593 P,1/3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter:
Address: | Surgical Specialties Corporation
100 Dennis Drive
Reading, PA 19606 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Contact Person: | 610 404 1000, ext. 2231
Betty Lazaro
Regulatory Affairs Specialtist |
| Date Prepared: | June 10, 2004 |
| Name of Device: | FeatherliftTM Extended Length Aptos Threads |
| Common / Usual
Classification Name: | GAW
Suture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Coapt Endotine Midface ST 4.5 device K032698 |
| Indications For Use: | Featherlift Aptos Extended Length Threads are
indicated for use in midface suspension surgery to
fixate the cheek subdermis in an elevated position. |
Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation
1
K041593
p2/3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Device Description | The threads are a blue, nonabsorbable, sterile,
surgical strand of polypropylene. The product is
USP size 2-0 polypropylene suture material 25
centimeters in length and incorporates a
unidirectional-cogged section 10 centimeters long
from the distal end. A 2 ¾ straight taper cutting
needle made of 400 series stainless steel will be
swedged to the proximal end. An introducer made
of 18 gauge stainless steel will be included for
placement of the Threads. The threads and the
introducer are supplied sterile for single use. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polypropylene sutures used PMA 870064,
K904906 for the fabrication of FeatherLift™
Extended Length Aptos Threads are commonly
used in medical applications where they are
implanted for tissue approximation in the body
indefinitely. Bench and animal evaluations have
demonstrated the Featherlift Extended Length
Aptos Threads to be safe and effective. |
| Performance Data: | Physical testing was conducted on the thread to
USP 27 for tensile strength, force required to
remove after implantation and Biocompatability for
permanent implantation, ISO 10993. |
Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation
2
Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text starts with the letters "Koy" followed by what looks like "D593". There is also a fraction-like expression of "3/3" with a subscripted "3" before the fraction.
Substantial Equivalence
The Featherlift™ Extended Length Aptos Thread is I no I can in use as its predicate device Endotine equivalent in 4.5 having the same intended use and indication for use except for the surgical technique of subperiosteal deployment. The fixation of subcutaneous tissue and elevation for both devices are achieved by tacking to the temporal fascia. They are anchored by suturing and tying to that fascia. The fixation surface area of the Featherlift Aptos Thread is more uniform, spread out over the entire midface providing a greater surface area of fixation compared to the Endotine Midface. The Material of the Featherlift Aptos Thread is made from a non absorbable polypropylene suture and will maintain its fixation indefinitely compared to the midface suspension device that is fabricated from a PGA equivalent material that looses significant strength and mass by 5 months. Therefore, the Featherlift Aptos Thread is substantially equivalent and offers some advantages over the predicate device, the Endotine Midface ST4.5.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2004
Mr. Richard G. Jones Vice President, Regulatory Affairs/Quality Assurance Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K041593
Ro41973
Trade/Device Name: Featherlift™ Extended Length Aptos Thread Regulation Number: 21 CFR 878.5010 Regulation Name: Polypropylene suture Regulatory Class: II Product Code: GAW Dated: September 7, 2004 Received: September 9, 2004
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levice your bected. B read free is substantially equivalent (for the indications relerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatise posice Americal Device American son to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been resulted in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that to not require appt to the general controls provisions of the Act. The 1 ou may, mercrore, manel are act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (socure) inc. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overnents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 issuaired or wouldevice complies with other requirements of the Act that I DA has made a decemmations administered by other Federal agencies. You must of any I cutures and regarance and regarants aincluding, but not limited to: registration and listing (21 Comply with an the Her Prequents (1) ); good manufacturing practice requirements as set OF It in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Richard G. Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your ence of your device to a legally premarket notheadon: "The FDA midning of basification 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 If you desire specific advice for your ac not on one of the more the regulation entitled, and Colliact the Office of Compuner as (be notification" (21CFR Part 807.97). You may obtain Misoranumly by reference to premansonsibilities under the Act from the Division of Small other gelleral information on your respendent Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
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
5
K04/593.
Page 6 revised
Indications for Use
510(k) Number (if known):
Device Name: Featherlift™Extended Length Aptos Thread
Indications For Use:
The Featherlift™Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Prescription Use
(Part 21 CFR 801 Subpart D)
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _ 1 ________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________________________________________________________________________________________________________