(753 days)
Not Found
No
The device description focuses on the mechanical operation of a manually operated suturing device and the properties of the sutures. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is described as a suturing system intended for placing sutures in skin and subcutaneous tissues, which is a medical intervention for treating wounds or incisions.
No
Explanation: The device is intended for the placement of sutures in the skin and subcutaneous tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a "hand-held, manually operated suturing device" which is a physical hardware component, not software.
Based on the provided text, the SafePath Suturing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "placement of a suture in the skin and subcutaneous tissues." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical suture and a hand-held device for placing it. This is consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The SafePath Suturing System is used in vivo (inside the body) for a surgical purpose.
N/A
Intended Use / Indications for Use
SafePath Suturing System - Silk Suture
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture
The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture
The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.
Product codes (comma separated list FDA assigned to the subject device)
GAP, GAR, GAW
Device Description
The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin and subcutaneous tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance Testing - Non-Clinical
Physical Testing:
Non-clinical testing has been performed in accordance USP (United States Pharmacopeia) Nonabsorbable Sutures - Diameter, Sutures- Needle Attachment, and Tensile Strength. In all cases, the USP criteria were met or exceeded.
Biocompatibility Testing:
The biocompatibility evaluation for the SafePath Suturing System (with silk suture and the suture passer) was referenced from the previously cleared SafePath submission K180701. For the nylon and polypropylene sutures, the safety evaluation was conducted based on the following considerations: (i)The nylon and polypropylene sutures are made from identical raw materials as the predicate device. (ii) The packaging and sterilization conditions are the same as those used for the predicate device. (iii) The manufacturing information from raw materials to the packaging was leveraged from the primary predicate device (K180701) for the silk suturing system.
A risk assessment was conducted on the raw materials and manufacturing processes for the nylon and polypropylene sutures to evaluate the safety of the device. The additional safety information was leveraged from the previously cleared K180701 submission.
For those tests conducted, the battery of testing included the following evaluations:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Hemocompatibility
- Pyrogenicity
- Endotoxicity
The SafePath Suturing System met the test criteria for each of the studies.
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
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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 shows 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" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
October 18, 2024
SafePath Medical, Inc. Howard Schrayer Regulatory Consultant 8 Lookout Hilton Head Island, South Carolina 29928
Re: K222944
Trade/Device Name: SafePath Suturing System-Silk Suture, SafePath Suturing System Polyamide Suture (Nylon), SafePath Suturing System- Polypropylene Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP, GAR, GAW Dated: May 22, 2023 Received: May 23, 2023
Dear Howard Schrayer:
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.
1
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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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/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-regulatory
2
assistance/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,
Tek N.
Lamichhane -S
Digitally signed by
Tek N. Lamichhane -S
Date: 2024.10.18
13:01:04 -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
3
Indications for Use
510(k) Number (if known) K222944
Device Name
SafePath Suturing System - Silk Suture SafePath Suturing System – Polyamide (Nylon) Suture SafePath Suturing System - Polypropylene Suture
Indications for Use (Describe)
SafePath Suturing System - Silk Suture
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture
The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.
| 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)
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510(k) SUMMARY – K222944 (Per 21 CFR 807.92)
General Company Information
| Name: | SafePath Medical, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 21 Water Street - 5th Floor |
| Amesbury, MA 01913 | |
| Telephone: | 978-697-3267 |
| Date Prepared | October 16, 2024 |
| General Device Information | |
| Product Name: | SafePath Suturing System – Silk Suture |
| Classification: | Silk Suture |
| Product code: GAP – Class II | |
| Regulation: | 21 CFR 878.5030 |
| Product Name: | SafePath Suturing System – Polyamide (Nylon) Suture |
| Classification: | Nylon Suture |
| Product code: GAR – Class II | |
| Regulation: | 21 CFR 878.5020 |
| Product Name: | SafePath Suturing System -Polypropylene Suture |
| Classification: | Polypropylene Suture |
| Product code: GAW – Class II | |
| Regulation: | 21 CFR 878.5010 |
| Classification: | Suture Passer |
| Product code: GAB - Class I | |
| Regulation: | 21 CFR 878.4800 |
| Predicate Devices | |
| Primary Predicate | SafePath Suturing System (with silk suture |
| SafePath Medical |
suture passer) [510(k) K180701] and
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Secondary Predicate Devices
| SM ENG CO Ltd. | REXLON® Nylon Suture
[510(k) K161633] |
|----------------|---------------------------------------------------|
| SM ENG CO Ltd. | REXLENE® Polypropylene Suture
[510(k) K173747] |
Description
The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.
Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.
6
Intended Use / Indications for Use
SafePath Suturing System - Silk Suture
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture
The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture
The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.
Substantial Equivalence
A table comparing the SafePath device with a predicate silk suture is provided below. This submission supports the position that the SafePath Suturing System is substantially equivalent to previously cleared devices, including those listed above. A number of predicate devices list the same clinical use.
SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Devices
SafePath Medical, Inc.
SafePath Suturing System - K180701 REXLON Nylon Suture - K161633 REXLENE Polypropylene Suture K173747 SafePath Suturing System K222944
Similarities and Differences
Silk suture is indicated for use in skin and subcutaneous tissue and other soft tissue applications, excluding use in cardiovascular and neural tissue
REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
SafePath silk suture is indicated for use in skin and subcutaneous tissue.
SafePath nylon suture is indicated for use in skin and subcutaneous tissue.
SafePath polypropylene suture is indicated for use in skin and subcutaneous tissue.
7
Regulation: 21 CFR 878.5030 Regulation: 21 CFR 878.5020 Regulation: 21 CFR 878.5010
Product code: GAP - Class II Product code: GAR - Class II Product code: GAW - Class II
Suture is provided with and without preattached (swaged) needle
Suture implant component is nonabsorbable.
Device is provided sterile for single-patientuse.
Suture is provided without a suture passer component
Silk suture is dyed black with logwood extract and coated with silicone for lubricity
Nylon suture is dyed black with logwood extract
Polypropylene suture is dyed blue with ([Phthalocyaninato (2-)] Copper)
Suture material is manufactured by Ashaway Line & Twine Mfg. Co.
Suture is provided with swaged, stainless steel needle
Suture passes all required tests for USP non-absorbable suture material and needle attachment
Silk suture is braided
Nylon suture is monofilament
Polypropylene suture is monofilament
Regulation: 21 CFR 878.5030 Regulation: 21 CFR 878.5020 Regulation: 21 CFR 878.5010
Product code: GAP - Class II Product code: GAR - Class II Product code: GAW - Class II
Suture is provided with pre-attached (swaged) needle
Suture implant component is nonabsorbable.
Device is provided sterile for single-patientuse.
Suture is pre-loaded in manually operated suturing device
Silk suture is dyed black with logwood extract and coated with silicone for lubricity
Nylon suture is dyed black with logwood extract
Polypropylene suture is dyed blue with ([Phthalocyaninato (2-)] Copper)
Suture material is manufactured by Ashaway Line & Twine Mfg. Co.
Suture is provided with swaqed, stainless steel needle
Suture passes all required tests for USP non-absorbable suture material and needle attachment
Silk suture is braided
Nylon suture is monofilament
Polypropylene suture is monofilament
8
Performance Testing - Non-Clinical
Physical Testing
Non-clinical testing has been performed in accordance USP (United States Pharmacopeia) Nonabsorbable Sutures - Diameter, Sutures- Needle Attachment, and Tensile Strength. In all cases, the USP criteria were met or exceeded.
Biocompatibility Testing
The biocompatibility evaluation for the SafePath Suturing System (with silk suture and the suture passer) was referenced from the previously cleared SafePath submission K180701. For the nylon and polypropylene sutures, the safety evaluation was conducted based on the following considerations: (i)The nylon and polypropylene sutures are made from identical raw materials as the predicate device. (ii) The packaging and sterilization conditions are the same as those used for the predicate device. (iii) The manufacturing information from raw materials to the packaging was leveraged from the primary predicate device (K180701) for the silk suturing system.
A risk assessment was conducted on the raw materials and manufacturing processes for the nylon and polypropylene sutures to evaluate the safety of the device. The additional safety information was leveraged from the previously cleared K180701 submission.
For those tests conducted, the battery of testing included the following evaluations:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
- Hemocompatibility ●
- Pyrogenicity
- Endotoxicity ●
The SafePath Suturing System met the test criteria for each of the studies.
9
Conclusions
SafePath Medical, Inc. believes that the information provided establishes that similar legally marketed devices including the referenced predicate devices, have been used for the same clinical application as the SafePath Medical SafePath Suturing System.
The safety and performance of the subject devices have been evaluated and found to be substantially equivalent to the referenced predicate devices.