(101 days)
The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
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
The provided document describes the SafePath Suturing System, a medical device. Based on the content, the acceptance criteria and the study that proves the device meets those criteria are focused on physical properties and biocompatibility of the suture itself, rather than AI/algorithm performance. There is no mention of an AI component in this device.
Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, human-in-the-loop performance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details) is not applicable to this device.
Here's a breakdown of the acceptance criteria and study information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Standards) | Reported Device Performance |
|---|---|
| Nonabsorbable Sutures - Diameter | Met or exceeded USP criteria |
| Sutures - Needle Attachment | Met or exceeded USP criteria |
| Tensile Strength | Met or exceeded USP criteria |
| Biocompatibility Testing (ISO-10993 Guidance) | |
| Cytotoxicity | Met test criteria |
| Sensitization | Met test criteria |
| Irritation | Met test criteria |
| Systemic Toxicity | Met test criteria |
| Hemocompatibility | Met test criteria |
| Pyrogenicity | Met test criteria |
| Endotoxicity | Met test criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "Physical Testing" and "Biocompatibility Testing," but does not specify the sample sizes used for these tests.
The data provenance is implied to be laboratory testing of the device components, not human or patient data.
- Data Provenance: Laboratory testing of the SafePath Suturing System components (sutures and overall system).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of device physical and biocompatibility testing. Ground truth here refers to established scientific/engineering standards (USP and ISO).
4. Adjudication Method for the Test Set:
Not applicable. Testing appears to be based on adherence to quantitative standards rather than expert consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this type of study is for evaluating diagnostic or interpretive AI systems. The SafePath Suturing System is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this pertains to AI/algorithm performance, which is not relevant to this device.
7. The Type of Ground Truth Used:
- Physical Testing: United States Pharmacopeia (USP) standards for Nonabsorbable Surgical Suture (Diameter, Needle Attachment, Tensile Strength).
- Biocompatibility Testing: FDA Guidance regarding the use of International Standards ISO-10993.
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set.
In summary, the SafePath Suturing System is a traditional medical device, and its acceptance criteria and testing focus on its physical properties, sterility, and biocompatibility in accordance with established medical device standards and regulations. The questions related to artificial intelligence and machine learning performance are not relevant to this specific device.
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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.
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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
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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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510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
·
| Name: | SafePath Medical, Inc. |
|---|---|
| Contact: | Howard SchrayerRegulatory Affairs Consultant |
| Address: | 21 Water Street - 5th FloorAmesbury, 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 SutureProduct code: GAP - Class II |
| Regulation: | 21 CFR 878.5030 |
| Classification: | Suture PasserProduct 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 suturePMA N11397 |
| Louisville Laboratories, Inc. | Carter-Thomason Needle-Point Suture Passer |
[510(k) K980123]
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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.
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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 andsubcutaneous tissue and other soft tissueapplications, excluding use incardiovascular and neural tissue | Silk suture is indicated for use in skin andsubcutaneous 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-patientuse. |
| Suture is provided without a suture passercomponent | Suture is pre-loaded in manually operatedsuturing device |
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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.
§ 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.