(27 days)
Not Found
No
The document describes a physical surgical suture and does not mention any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is a barbed suture used for soft tissue approximation, which directly participates in the treatment of wounds or surgical incisions.
No
The device is a surgical suture used for approximating soft tissues. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a monofilament, flexible thread made from a polymer, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation excluding closure of the epidermis." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical suture used to hold tissues together.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
Product codes
GAW
Device Description
The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament.
The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K652373₁/₃
SEP 2 6 2005
Section 5 - 510(k) Summary
Applicant Contact: 1.
Lois Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, NC 27713 Phone: 919-806-1961 Fax: 919-806-1953 Email: Ismart@quillmedical.com
Date Prepared: August 29, 2005
- Name of Device: Quill® Nonabsorbable Polypropylene Barbed Suture 2. Nonabsorbable Polypropylene Surgical Suture Common Name: Nonabsorbable Polypropylene Surgical Suture Classification Name: Regulation 21 CFR 878.5010, Product Code GAW
Identification of device(s) to which the submitted claims equivalence: 3.
The Quill® Nonabsorbable Polypropylene Barbed Suture is substantially equivalent to the following predicate devices:
- For Material / Technological Characteristics: .
- Contour Midface Opposing Unidirectional Threads™ by Surgical 피 Specialties Corp., 510k K050548
- For Indication for Use based on Technological Characteristics: .
- Ouill® Synthetic Absorbable Barbed Suture by Quill Medical, Inc., 510k ■ K051609
4. Device Description:
The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament.
The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
1
K052373²/₃
Section E - 510(k) Summary (continued)
ડ. Intended Use of the Device:
Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
Technological characteristics of the device in comparison to those of the 6. predicate device(s)
Indication for Use Comparison:
The Quill® Nonabsorbable Polypropylene Barbed Suture is equivalent in its intended use of soft tissue approximation to the Quill® Synthetic Absorbable Barbed Suture.
Material and Technology Comparison:
The Quill® Nonabsorbable Polypropylene Barbed Suture is equivalent to the predicate device as shown in the table below:
| | Quill® Nonabsorbable Polypropylene
Barbed Suture,
510(k) TBD | Contour Midface Opposing
Unidirectional Threads™,
510(k) K050548 |
|---------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Product Code | GAW | GAW |
| Technique of
Deployment | Attached needles. | Attached needles. |
| Technological
Characteristic | Bi-directional barbs along the long axis
of the suture monofilament. | Bi-directional barbs along the long axis
of the suture monofilament. |
| Material | Polypropylene (cleared per K904906) | Polypropylene (cleared per K904906) |
| Sterilization | EO | EO |
| Packaging | Identical (device wound onto cardboard
inner support card and packaged in a
Tyvek pouch) | Identical (device wound onto cardboard
inner support card and packaged in a
Tyvek pouch) |
2
K052373
7/3
Section E - 510(k) Summary (continued)
7. Safety and Performance:
The difference between the Quill® Nonabsorbable Polypropylene Barbed Suture and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the barbed suture. The Quill® Synthetic Absorbable Barbed Suture employs the same technological characteristics to support the intended use of soft tissue approximation of the nonabsorbable fiber (polypropylene) used in the Contour Midface Opposing Unidirectional Threads™. In addition, polypropylene is commonly used in medical applications and has proven to be biocompatible. The device, as designed, is as safe and effective as its predicate devices.
Conclusion 8.
Based on the design, material, function and intended use discussed herein, Quill Medical believes the Quill® Nonabsorbable Polypropylene Barbed Suture is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lois V. Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, North Carolina 27713
Re: K052373
Trade/Device Name: Quill® Nonabsorbable Polypropylene Barbed Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: August 29, 2005 Received: August 30, 2005
Dear Ms. Smart:
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.
4
Page 2- Ms. Lois V. Smart
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
Sincerely yours,
Barbara Pouehund
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
052373
Section 4 - Indications for Use Statement
510k number if known:
Quill® Nonabsorbable Polypropylene Barbed Suture Device Name:
Indications for Use:
Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for soft tissue approximation excluding closure of the epidermis.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chubare Buchus for MXM
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K052373