(43 days)
Not Found
No
The document describes a surgical suture and its physical properties and testing, with no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device, a surgical suture, is used for tissue approximation and ligation, which are procedures that aid in healing but do not directly treat a disease or condition.
No
The document describes a surgical suture for tissue approximation and/or ligation, which is a therapeutic device, not a diagnostic one.
No
The device is a physical surgical suture, not a software application. The description details its material composition, physical properties, and intended use in soft tissue approximation and ligation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "surgical suture." Sutures are used to close wounds or hold tissues together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical tool used in vivo (within the body) during a procedure.
N/A
Intended Use / Indications for Use
Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
NWJ
Device Description
Tornier, Inc. Phantom Fiber BioFiber Suture is a n absorbable, braided, sterile, surgical USP size 2 suture composed of poly(4-hydrobutyrate) (P4HB) with cyanoacrylate adhesive tipped ends. Phantom Fiber BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
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)
Phantom Fiber BioFiber Suture was subjected to FDA Special Controls required USP testing such as; suture tensile strength, suture diameter, suture needle attachment strength; as well as non USP testing. The non USP testing included in-vivo degradation testing of product strength over time and residual molecular weight. The results of this non-clinical testing allow us to conclude that the Phantom Fiber BioFiber Suture described in this submission is substantially equivalent and as safe and effective as the predicate device.
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
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).
0
Page 1/3
510(k) Summary for K130422
4 2013 APR
Tornier, Inc. Phantom Fiber BioFiber Suture
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
Trade name: Phantom Fiber BioFiber Suture
Common name: Suture, recombinant technology
Classification Number/ Classification name/Product code:Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology are class II devices under 21 CFR § 878.4494 (product code NWJ) and are classified by the General and Plastic Surgery Devices Panel.
2) Submitter
Tornier, Inc. 10801 Nesbitt Avenue Bloomington, MN 55437 Registration Number: 9100540
- Company contact
Lael J. Pickett Regulatory Affairs Tornier, Inc. 10801 Nesbitt Avenue Bloomington, MN 55437 USA Telephone: 612-219-7350/Fax: 952-426-7601 Email: Ipickett@tornier.com
- Classification
Device class: Class II
Classification panel: General and Plastic Surgery Devices
Product code: NWJ
Special Controls: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
1
K130422 page 2/3
5) Legally Marketed Device to which Equivalence is Claimed
Tornier BioFiber Suture (K122487).
6) Comparison to Predicate Device
| Feature | From: Tornier BioFiber Suture
(K122487) | To: Tornier Phantom Fiber
BioFiber Suture |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Indications for
Use | For use in general soft tissue
approximation and/or ligation, but not
for use in cardiovascular or
neurological tissues, microsurgery or
ophthalmic surgery. | Same. |
| Design | | |
| Composition | P4HB | Same |
| Needles attached | Available with and without needles
attached | Same |
| USP Size | Size 2 | Same |
| Design | Braided | Same |
| Colors | Un-dyed (natural) or dyed (D&C Violet
No. 2) | Same |
| Performance | | |
| USP
Suture diameter | Compliant for size 2, except that the
diameter is slightly larger | Same |
| USP
Suture Needle
Attachment | Compliant for size 2 | Same |
| USP
Tensile Strength | Compliant for size 2 | Same |
7) Device description
Tornier, Inc. Phantom Fiber BioFiber Suture is a n absorbable, braided, sterile, surgical USP size 2 suture composed of poly(4-hydrobutyrate) (P4HB) with cyanoacrylate adhesive tipped ends. Phantom Fiber BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.
8) Indications for Use
Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
2
K130422 Page 3/3
9) Summary of technologies
Phantom Fiber BioFiber Suture was subjected to FDA Special Controls required USP testing such as; suture tensile strength, suture diameter, suture needle attachment strength; as well as non USP testing. The non USP testing included in-vivo degradation testing of product strength over time and residual molecular weight. The results of this non-clinical testing allow us to conclude that the Phantom Fiber BioFiber Suture described in this submission is substantially equivalent and as safe and effective as the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: April 4, 2013
Tornier, Inc. % Ms. Lael J. Pickett Regulatory Affairs 10801 Nesbitt Avenue Bloomington, Minnesota 55437
Re: K130422
Trade/Device Name: Phantom Fiber Biofiber Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly (hydroxybutyrate) surgical suture produced by recombinant DNA technology Regulatory Class: Class II Product Code: NWJ Dated: March 06, 2013
Received: March 12, 2013
Dear Ms. Pickett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Lael J. Pickett
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nielkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130422
Device Name: Tornier, Inc. Phantom Fiber™ BioFiber™ Suture
Indications for Use
Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130422