(86 days)
No
The summary describes a surgical suture made of UHMWPE. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and USP requirements.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive rather than a therapeutic function.
No
Explanation: The device is described as a surgical suture used for approximation and ligation of soft tissue. It is an implantable device used in procedures, not for diagnosing conditions or diseases.
No
The device description clearly states it is a surgical suture made of physical materials (UHMWPE) and is intended for physical tissue approximation and ligation. There is no mention of software components.
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, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures." This describes a device used within the body for surgical procedures, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The device is described as "non-absorbable, sterile, surgical sutures" and "surgical braids" made of UHMWPE. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples like blood, urine, tissue, etc., or providing diagnostic results. The performance studies focus on physical properties like tensile strength and needle attachment, which are relevant to surgical sutures, not IVDs.
In summary, the HyperSuture All Blue Extension Line is a surgical suture intended for use during surgery, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.
HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).
Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Threadstone HyperSuture All Blue Extension Line sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia. The HyperSuture All Blue Extension Line sutures are tested per USP performance requirements for diameter, needle attachment and tensile strength. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices as specified in the provided MAF.
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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 09, 2024
Threadstone L.L.C. Jeremy Clark President 1035 Benfield Blvd Suite H Millersville, Maryland 21108
Re: K241376
Trade/Device Name: HyperSuture All Blue Extension Line Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: June 14, 2024 Received: June 14, 2024
Dear Jeremy Clark:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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/cdrh-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, Digitally signed by Tek N Tek N. Lamichhane -S Lamichhane -S Date: 2024.08.09 23:55:26 -04'00 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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
Submission Number (if known)
Device Name
HyperSuture All Blue Extension Line
Indications for Use (Describe)
HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Threadstone HyperSuture™ All Blue Extension Line (K241376)
1. Submitter Information
| Submitter's Name: | Threadstone L.L.C. |
|---|---|
| Address: | 1035 Benfield Blvd, Suite H, |
| Millersville, MD 21163, USA | |
| Phone Number: | 443-790-6536 |
| Fax Number: | N/A |
| Registration Number: | 3017499940 |
| Contact Person: | Jeremy Clark |
| Office@Threadstoneusa.com |
09AUG2024
Date of Preparation:
2. Device Name
| Trade Name: | HyperSuture™ All Blue Extension Line |
|---|---|
| Common or Usual Names: | Polyblend Suture, Non-absorbable Surgical Sutures |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) Surgical |
| Suture |
3. Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 878.5000: Suture, nonabsorbable, synthetic, polyethylene |
| Classification Code: | GAT |
| Review Panel: | General & Plastic Surgery |
| Premarket Review: | Office of Device Evaluation |
| Division of Surgical Devices, Plastic and Reconstructive | |
| General Surgery Devices Branch |
4. Predicate Device
Primary Predicate: K230311 – HyperSuture™ Reference Device: K181774 - Force Fiber® Suture
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5. Device Description
HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.
HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).
Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.
6. Intended Use / Indication for Use
HyperSuture All Blue Extension Line sutures (both cables and tapes) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
7. Substantial Equivalence and Comparison of Technical Characteristics
The Threadstone HyperSuture All Blue Extension Line devices are substantially equivalent to the previously cleared HyperSuture cleared under K230311. The HyperSuture All Blue Extension Line devices have the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the HyperSuture All Blue Extension Line and the predicate devices are manufactured, packaged, and EO sterilized using identical processes, are composed of the same material (UHMWPE), and are tested per USP performance requirements for length, tensile strength and needle attachment.
The only change made for the HyperSuture All Blue Extension Line compared to HyperSuture (K230311) is the use of blue UHMWPE dyed with blue color additive (Chromium-Cobalt-Aluminum Oxide) instead of undyed, white UHMWPE.
Other technological characteristics such as materials, dimensions, sterilization, manufacturing processes, mechanical strengths (i.e., tensile strength, and needle attachment strength), shelf-life, packaging, and labels are unaffected by this change.
These differences do not raise new questions of safety or effectiveness as it will be discussed in the risk analysis: therefore. the HyperSuture All Blue Extension Line suture product family is substantially equivalent to the currently marketed predicate device.
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8. Performance Data
The Threadstone HyperSuture All Blue Extension Line sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia. The HyperSuture All Blue Extension Line sutures are tested per USP performance requirements for diameter, needle attachment and tensile strength. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices as specified in the provided MAF.
9. Conclusion
The information provided in this traditional 510(k) demonstrates that the Threadstone HyperSuture All Blue Extension Line devices are substantially equivalent to the predicate sutures cleared under K230311.