(73 days)
Not Found
No
The summary describes a physical surgical suture and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an absorbable surgical suture used for approximation and/or ligation of soft tissues, which functions to aid the healing process after an injury or surgery, rather than directly treating a disease or condition.
No
Explanation: The device is an absorbable surgical suture used for approximation and/or ligation of soft tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate," which is a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Description: The description clearly states that the BioElast™ 5-0 Suture is a "sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate." This is a physical device used within the body for surgical purposes.
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on the patient's tissues.
The information provided describes a surgical implant/device, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
BioElast™ 5-0 absorbable sutures are 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
NWJ
Device Description
BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4- hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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)
Results of bench and in-vivo testing demonstrate that the BioElast™ 5-0 Suture is biocompatible and substantially equivalent in function to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tepha, Inc., TephaFLEX® Absorbable Suture, Ethicon, Inc., PDS*II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) NumberKo72470
510(k) SUMMARY
| Trade Name: | BioElast™ 5-0 Suture | NOV 16 2007 |
|---|---|---|
| Sponsor: | ENTrigue Surgical, Inc. | |
| 3463 Magic Drive, Suite 320 | ||
| San Antonio, Texas 78229 | ||
| Telephone: 1-866-300-5010 | ||
| Fax: 1-210-582-5811 | ||
| Contact Person: Gabriele G. Niederauer, Ph.D. | ||
| Date of Summary: | August 31, 2007 | |
| Device Classification Name: | 21 CFR §878.4494 | |
| Absorbable Poly(hydroxybutyrate) Surgical Suture | ||
| Classification: | According to Section 13 of the Federal Food, Drug | |
| and Cosmetic Act, the device classification is Class II | ||
| Performance Standards. | ||
| Predicate Devices: | Tepha, Inc., TephaFLEX® Absorbable Suture | |
| Ethicon, Inc., PDS*II | ||
| Device Description: | BioElast™ 5-0 Suture is a sterile, monofilament, | |
| absorbable surgical suture composed of poly-4- | ||
| hydroxybutyrate. The BioElast™ 5-0 Sutures will be | ||
| provided undyed at a 5-0 size. | ||
| Indications for Use: | BioElast™ 5-0 absorbable sutures are indicated for | |
| use in general soft tissue approximation and/or | ||
| ligation, but not for use in cardiovascular or | ||
| neurological tissues, microsurgery or ophthalmic | ||
| surgery. | ||
| Safety and Performance: | Results of bench and in-vivo testing demonstrate that | |
| the BioElast™ 5-0 Suture is biocompatible and | ||
| substantially equivalent in function to the predicate | ||
| devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a symbol and surrounding text. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ENTrigue Surgical, Inc. % Gabriele G. Niederauer, PhD VP, Research & Development 3463 Magic Drive, Suite 320 San Antonio, Texas 78229
Re: K072470
Trade/Device Name: BioElast™ 5-0 Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Suture, recombinant technology Regulatory Class: II Product Code: NWJ Dated: August 13, 2007 Received: September 4, 2007
Dear Dr. Niederauer
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.
2
Page 2 - Gabriele G. Niederauer, PhD
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Device Name: BioElast™ 5-0 Suture
Indications for Use:
BioElast™ 5-0 absorbable sutures are 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 区
AND/OR
Over-The-Counter Use □
(Part 21 C.F.R. 801 Subpart D)
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oil) Division of General, Restorative, and Neurological Devices
510(k) Number 10012470
Page 1 of 1