(101 days)
Not Found
No
The description focuses on the mechanical operation of the device and the properties of the suture material. There is no mention of AI or ML capabilities.
No.
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device is described as a "Suturing System" intended for "placement of a silk suture in the skin and subcutaneous tissues," which is a procedural tool rather than a therapeutic treatment itself.
No
The SafePath Suturing System is described as a device for placing sutures in skin and subcutaneous tissues, which is a therapeutic rather than a diagnostic function. Its description focuses on the physical components and mechanism of action for suturing, with no mention of sensing, measuring, or analyzing physiological data to diagnose a condition.
No
The device description explicitly details physical components including a silk suture, a needle, and a hand-held, manually operated suturing device. There is no mention of software as a component of the system.
Based on the provided information, the SafePath Suturing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "placement of a silk suture in the skin and subcutaneous tissues." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "hand-held, manually operated suturing device" that places a suture. This is a surgical tool.
- Anatomical Site: The device is used on "skin and subcutaneous tissues," which are parts of the living body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body in vitro (outside the body) to provide information for diagnostic purposes. The SafePath Suturing System is a surgical device used in vivo (within the living body) for wound closure.
N/A
Intended Use / Indications for Use
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
Product codes (comma separated list FDA assigned to the subject device)
GAP, GAB
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 30 in. length, swaged on 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.
The System Includes:
(2) Suturing Device Pre-loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a ½ circle, 26 mm reverse cutting needle
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
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)
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 was conducted in accordance with FDA Guidance regarding the use of International Standards ISO-10993.
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 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.
June 25, 2018
SafePath Medical, Inc. Mr. Howard Schrayer Official Correspondent 21 Water Street - 5th Floor Amesbury, Massachusetts 01913
Re: K180701
Trade/Device Name: SafePath Suturing System Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: May 24, 2018 Received: May 25, 2018
Dear Mr. 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 (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. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180701
Device Name SafePath™ Suturing System
Indications for Use (Describe)
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
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 (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 |
| Fax: | 978-636-4174 |
| Date Prepared | March 15, 2018 |
| General Device Information | |
| Product Name: | SafePath Suturing System |
| Classification: | Silk Suture |
| Product code: GAP - Class II | |
| Regulation: | 21 CFR 878.5030 |
| Classification: | Suture Passer |
| Product code: GAB - Class I | |
| Regulation: | 21 CFR 878.4800 |
| Predicate Devices | |
| SM ENG CO Ltd. | REXSIL® Silk Suture |
| [510(k) K161633] | |
| Ethicon, Inc. | USP non-absorbable silk suture |
| PMA N11397 | |
| Louisville Laboratories, Inc. | Carter-Thomason Needle-Point Suture Passer |
[510(k) K980123]
4
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 30 in. length, swaged on 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.
The System Includes:
(2) Suturing Device Pre-loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a ½ circle, 26 mm reverse cutting needle
Intended Use (Indications)
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
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 was conducted in accordance with FDA Guidance regarding the use of International Standards ISO-10993.
5
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.
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.
| SM ENG CO Ltd. | SafePath Medical, Inc. |
|---|---|
| REXSIL® Silk Suture | SafePath Suturing System |
| 510(k) K161633 | TBD |
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 | Silk suture is indicated for use in skin and
subcutaneous tissue |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Regulation: 21 CFR 878.5030 | Regulation: 21 CFR 878.5030 |
| Product code: GAP - Class II | Product code: GAP - Class II |
| Suture is provided with and without pre-
attached (swaged) needle | Suture is provided with pre-attached
(swaged) needle |
| Silk suture implant component is non-
absorbable. | Silk suture implant component is non-
absorbable. |
| Device is provided sterile for single-
patient-use. | Device is provided sterile for single-patient
use. |
| Suture is provided without a suture passer
component | Suture is pre-loaded in manually operated
suturing device |
6
Suture is dyed black with logwood extract and coated with silicone for lubricity
Braided 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
Suture is dyed black with logwood extract and coated with silicone for lubricity
Braided 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
Conclusions
SafePath Medical , Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical application as the SafePath Medical SafePath Suturing System. The materials from which the SafePath Medical device is fabricated have an established history of use, and the devices have been developed in accordance with applicable FDA guidelines.