(294 days)
Not Found
No
The device description focuses solely on the material composition and physical properties of surgical sutures (cables and tapes). There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies described are standard material and mechanical property tests for sutures, not evaluations of algorithmic performance.
No.
The device is a surgical suture used for approximation and/or ligation of soft tissue, which is a supportive rather than a therapeutic function.
No
The device is described as surgical sutures used for general soft tissue approximation and/or ligation, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical surgical suture made of UHMWPE, available in different forms (cables and tapes) and sizes, with or without needles. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The device is a surgical suture, a physical implant used to hold tissue together. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
The information provided clearly describes a surgical device used for physical repair within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HyperSutures (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
GAT
Device Description
HyperSuture 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 cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.
HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (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 Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).
Both HyperSuture cables and tapes are available in white/black, 40 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
general soft tissue, cardiovascular, orthopedic
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
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Summary of Performance Studies
HyperSuture sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia. HyperSuture cables are tested per USP performance requirements for diameter, needle attachment and tensile strength. HyperSuture tapes are tested per USP performance requirements for tensile strength and needle attachment strength and Threadstone specifications for the tape width. 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 10993-1:2018 - Biological Evaluation of Medical Devices. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 24, 2023
Threadstone L.L.C. Jeremy Clark President 1035 Benfield Blvd. Suite H Millersville, Maryland 21108
Re: K230311
Trade/Device Name: HyperSuture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 25, 2023 Received: October 26, 2023
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"
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(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).
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: 2023.11.24 07:54:48
11.24 07:54:48 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230311
Device Name HyperSuture
Indications for Use (Describe)
HyperSutures (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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Threadstone HyperSuture (K230311)
1. Submitter Information
| Submitter's Name: | Threadstone L.L.C. |
|---|---|
| Address: | 1035 Benfield Blvd, |
| Suite H, Millersville, | |
| MD 21163, USA | |
| Phone Number: | (410) 544-2833 |
| Fax Number: | N/A |
| Registration Number: | 3017499940 |
| Contact Person: | Jeremy Clark, |
| Office@Threadstoneusa.com | |
| Date of Preparation: | 11/22/2023 |
2. Device Name
| Trade Name: | HyperSuture™ |
|---|---|
| Common or Usual Names: | Polyblend Suture, Non-absorbable Surgica l |
| Sutures Classification Name: | Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture |
3. Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 21CFR §878.5000: Suture, nonabsorbable, synthetic, polyethylene |
| Classification Code: | GAT |
| Review Panel: | General & Plastic Surgery |
| 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
K181774 – Force Fiber Suture and Force Fiber OrthoTape Suture
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5. Device Description
HyperSuture 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 cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.
HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (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 Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).
Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.
6. Intended Use / Indication for Use
HyperSuture 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
HyperSuture product family is substantially equivalent to the previously cleared Force Fiber Suture and Force Fiber OrthoTape. The HyperSuture product family has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device, Force Fiber Suture and Force Fiber OrthoTape cleared per K181774. Both the HyperSuture and the predicate device are sterilized using the same processes (EO Sterilization), are composed of the same material (UHMWPE), and are tested per USP performance requirements for length, tensile strength and needle attachment. The minor differences in technical characteristics are limited to the needle material, needle shapes and needle tips. The HyperSuture product family utilizes AISI 302 stainless steel needle with 1/2 circle curvature and taper cutting which is a subset of needle shape and tips provided by the predicate sutures. These differences do not raise new questions of safety or effectiveness as it will be discussed in the performance data; therefore, the HyperSuture suture product family is substantially equivalent to the currently marketed predicate device.
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8. Performance Data
HyperSuture sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia. HyperSuture cables are tested per USP performance requirements for diameter, needle attachment and tensile strength. HyperSuture tapes are tested per USP performance requirements for tensile strength and needle attachment strength and Threadstone specifications for the tape width. 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 10993-1:2018 - Biological Evaluation of Medical Devices. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers."
9. Conclusion
The information provided in this 510(k) demonstrates that HyperSuture™ (K230311) is substantially equivalent to the predicate sutures cleared under K181774.