(28 days)
No
The 510(k) summary describes a traditional medical device (suture) and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a suture used for approximating and/or ligating soft tissues, which is a surgical tool rather than a therapeutic device designed to treat a disease or condition itself.
No
Explanation: This device is an absorbable monofilament suture used for tissue approximation and/or ligation. Its purpose is to physically join tissues, not to diagnose a condition or disease.
No
The device description clearly states it is a monofilament suture, which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general soft tissue approximation and/or ligation." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical suture made of a polymer. This is a physical implant/device used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. This device does not perform any such analysis.
The information provided describes a surgical suture, which is a medical device used for closing wounds and holding tissues together during surgery.
N/A
Intended Use / Indications for Use
GalaSTITCH™ Absorbable Monofilament 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
NWJ
Device Description
GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue approximation and/or ligation
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
The GalaSTITCH suture is identical to the TephaFLEX predicate; therefore, no additional testing was necessary to demonstrate safety and performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 27, 2021
Tepha, Inc. Jodie Giordano Sr Regulatory Specialist 99 Hayden Avenue, Suite 360 Lexington. Massachusetts 02421
Re: K211307
Trade/Device Name: GalaSTITCH Absorbable Monofilament 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: April 28, 2021 Received: April 29, 2021
Dear Dr. Giordano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Cindy Chowdhury, Ph.D., MBA Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211307
Device Name
GalaSTITCH Absorbable Monofilament Suture
Indications for Use (Describe)
GalaSTITCH™ Absorbable Monofilament 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 1.
| Submitter | ||
|---|---|---|
| Company Name: | Tepha, Inc. | |
| Address: | 99 Hayden Avenue, Suite 360 | |
| Lexington, MA 02421 | ||
| Telephone: | 781-475-8849 | |
| Fax: | 781-357-1701 | |
| Contact Person: | Jodie Giordano, PhD | |
| Senior Regulatory Affairs Specialist | ||
| Date Prepared : | April 28, 2021 | |
| 2. | ||
| Device | ||
| Trade Name: | GalaSTITCH™ Absorbable Monofilament Suture | |
| Classification Name: | Absorbable Poly(hydroxybutyrate) Surgical Suture produced by | |
| recombinant DNA technology | ||
| Classification Reg/Panel: | CFR §878.4494 / General and Plastic Surgery | |
| Product Code: | NWJ | |
| 3. | ||
| Predicate Device | ||
| Predicate Name/510(k) Number | TephaFLEX™ Absorbable Monofilament Suture | |
| (K082178) | ||
| Reference Devices: | Stratafix Spiral PDS Plus (K192144) | |
| Maxon Monofilament (K990951) |
Device Description
GalaSTITCH Absorbable Monofilament Suture (GalaSTITCH) is identical to the predicate TephaFLEX Absorbable Monofilament Suture (TephaFLEX) in regard to materials, design, and manufacturing processes. The product is being rebranded and will be commercialized by Tepha, Inc.'s wholly owned subsidiary, Galatea. GalaSTITCH is constructed of poly-4-hydroxybutyrate (P4HB) which is a biologically derived polymer that is extruded into monofilament fibers. The sterile P4HB suture is offered as undyed (clear) and dyed (violet) and meets all standards (except diameter) set by the United States Pharmacopeia (USP) for synthetic absorbable sutures. P4HB bioabsorbs through a process of hydrolysis and hydrolytic enzymatic digestion.
4
4. Indications for Use
GalaSTITCH™ Absorbable Monofilament 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.
The indications for use statement for GalaSTITCH is identical to the TephaFLEX predicate device.
న్. Comparison of Technological Characteristics with the Predicate Device
The proposed GalaSTITCH suture is substantially equivalent to TephaFLEX suture because it is identical in regard to materials, design, manufacturing processes, and intended use. The following modifications are exclusive to product labeling do not impact the fundamental scientific technology and intended use of the previously cleared device.
The purpose of this Special 510(k) submission is to notify the FDA of two main changes being made to the labeling of the predicate TephaFLEX suture (K082178):
-
- The TephaFLEX Absorbable Monofilament Suture will be rebranded (renamed) and will be commercialized through Tepha's wholly owned subsidiary, Galatea, as the GalaSTITCH Absorbable Monofilament Suture.
-
- The predicate TephaFLEX IFU currently includes a contraindication statement as follows:
TephaFLEX™ Absorbable Monofilament sutures should not be used where permanent support is required or in conjunction with prosthetic devices or grafts.
For clarification purposes, Tepha is adding the content in bold to the contraindication statement as follows:
GalaSTITCH™ absorbable monofilament surgical suture should not be used where permanent support is required or in conjunction with permanent prosthetic devices or grafts (e.g., heart valves or synthetic grafts).
-
- Safety and Performance Data
There have been no changes to the P4HB material, design specifications, or the manufacturing processes for purposes of this submission. The GalaSTITCH suture is identical to the TephaFLEX predicate; therefore, no additional testing was necessary to demonstrate safety and performance.
- Safety and Performance Data
7. Conclusions
GalaSTITCH™ Absorbable Monofilament Suture is substantially equivalent to the predicate device based on the identical intended use and identical technological characteristics, and clarifying labeling changes that are consistent with language cleared in the reference device submissions.