(311 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for approximation of soft tissue, which is not considered a therapeutic function that alleviates or cures a disease or condition. Its purpose is mechanical support during healing.
No
Explanation: The device, APTOS Threads - Polypropylene Surgical Sutures, is described as a surgical strand for general soft tissue approximation. Its indications and description do not mention any diagnostic function; instead, it is used for surgical procedures.
No
The device description clearly states it is a physical surgical suture made of polypropylene with needles attached, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "general soft tissue approximation, excluding closure of the epidermis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture, a physical object used to hold tissue together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
Product codes
GAW
Device Description
APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin.
The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives.
The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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
Biocompatibility testing was performed in accordance with ANSVAAMI/ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process, as well as FDA's 2016 guidance document "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Specific testing included the following:
Cytotoxicity, ISO 10993-5
Sensitization, ISO 10993-10
Irritation, ISO 10993-10
Acute systemic Toxicity, ISO 10993-11
Materials Mediated Pyrogenicity, ISO 10993-11
Implantation, ISO 10993-6
Hemocompatibility, ISO 10993-4, ASTM F756-17
Subchronic Toxicity, 90-day Subchronic Intramuscular Implantation, ISO 10993-11
Genotoxicity, Ames Bacterial Reverse Mutation Assay, OECD 471
Genotoxicity: In Vivo Mouse Micronucleus Mutagenicity Assay, OECD 487
Genotoxicity: Mouse Lymphoma Assay, OECD 476
Bacterial Endotoxin Test, USP
Bench Testing:
Physical testing was performed to establish compliance with:
USP suture diameter
USP suture attachment
USP tensile strength
Ex-vivo tissue holding strength testing was conducted compared to the predicate to demonstrate substantially equivalent tissue holding strength.
Ethylene Oxide sterility validation testing was conducted in accordance with overkill half-cycle methods per ISO 11135:2014 to demonstrate SAL 10-6. Residuals were evaluated in accordance with ANSI/AAMI/ISO 10993-7:2008/(R) 2012.
Shelf life testing involved package integrity and seal strength testing subsequent to environmental preconditioning and distribution simulation, in accordance with AAMI/ISO 11607-1: 2006 (R) 2010, ASTM D4169-16, ASTMF88/F88M-15, and ASTM F2096-11.
Key Metrics
Not Found
Predicate Device(s)
FilBloc Permanent Sutures (K171039)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 27, 2020
Aptos, LLC. Nikolai Pirtskhalaichvili Vice President of Operations 20/4 V. Orbeliani Street Tbilisi, 0105 Ge
Re: K192953
Trade/Device Name: APTOS Threads - Polypropylene Surgical Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: October 18, 2019 Received: October 21, 2019
Dear Nikolai Pirtskhalaichvili:
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. 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 located 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.
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) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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.
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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
510(k) Number (if known) K192953
Device Name
APTOS Threads - Polypropylene Surgical Sutures
Indications for Use (Describe)
The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
| 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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3
Submission Date: October 21, 2019
SUBMITTER 1.
APTOS, LLC. 20/4 V. Orbeliani Street T'bilisi Georgia, 0105
Contact Person: Tamara Beshidze Phone: +99532 2920371/Ext 533 Email: tamara.beshidze@aptos.ge
DEVICE 2.
Device Trade Name: APTOS Threads - Polypropylene Surgical Sutures Common Name: Nonabsorbable polypropylene surgical suture Classification Regulation: 21 CFR 878.5010 Regulatory Class: II Product Code: GAW Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Device: FilBloc Permanent Sutures (K171039)
DEVICE DESCRIPTION 4.
APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin.
The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives.
The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.
4
INDICATIONS FOR USE ട്.
The APTOS Threads – Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The proposed device is a barbed suture device with very similar physical characteristics to the predicate. Both devices are constructed from polypropylene and possess barbs to achieve the intended use of approximation of tissue.
The FilBloc Permanent Suture device does have some differences, as it has a wider variety of designs and options, such as unidirectional barbs, non-barbed sutures. The proposed device configuration is the same design as one of the predicate configuration, i.e. size 2-0 sutures with bidirectional barbs.
The similarities and differences in technological characteristics between the subject APTOS Threads - Polypropylene Surgical Sutures and the predicate sutures are summarized below.
| Proposed New Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K192953 | K171039 |
| Applicant | AMAP International, Inc. | Assut Europe, Italy |
| Device Name | APTOS Threads – Polypropylene | |
| Surgical Sutures | FilBloc Permanent Sutures | |
| Classification | ||
| Regulation | 21 CFR 878.5010 | 21 CFR 878.5010 |
| Product Code | GAW | GAW |
| Indication | Aptos Threads – Polypropylene | |
| Surgical Sutures are indicated for | ||
| general soft tissue approximation, | ||
| excluding closure of the epidermis, | ||
| where use of a non-absorbable suture | ||
| is appropriate. | FilBloc Permanent sutures are intended | |
| for general soft tissue approximation, | ||
| excluding closure of the epidermis, | ||
| where use of a non-absorbable suture | ||
| is appropriate. | ||
| Proposed New Device | Predicate Device | |
| Design | APTOS Threads – Polypropylene | |
| Surgical Sutures incorporate a | ||
| bidirectional barbed design. The | ||
| threads are supplied with needles | ||
| attached to both ends. The thread's | ||
| upper and lower anchoring sections | ||
| are barbed in opposite direction with | ||
| a small unbarbed section between | ||
| them and two smooth unbarbed | ||
| sections, each immediately adjacent | ||
| to needle-thread attachment | ||
| interfaces. The needles are | ||
| constructed from 420B stainless steel. | ||
| Standard needle attachment. | Device Description: | |
| The Assut FilBloc Permanent Suture range | ||
| of devices comprises a variety of gauge | ||
| sizes and lengths, | ||
| supplied with or without stainless steel | ||
| needles, which are also available in a | ||
| variety of different sizes and shapes. | ||
| The sutures may have a 'block' at one end, | ||
| which allows surgeons to close wounds | ||
| quickly and securely without tying knots | ||
| or changing suturing techniques. The block | ||
| is made from the same material as the | ||
| suture, and is used to anchor the suture. | ||
| The suture thread can be smooth or can | ||
| have unidirectional or bidirectional barbs | ||
| along the axis of the monofilament surface, | ||
| either convergent or divergent. | ||
| Rx Only? | Yes | Yes |
| Suture Barbs | Bi-Directional | None |
| Bidirectional | ||
| Unidirectional | ||
| Materials | Polypropylene Monofilament | Polypropylene Monofilament |
| Dyed | phthalocyanine copper - C.I. 74160; | |
| 21 CFR§ 74.3045 | phthalocyanine copper - C.I. 74160; 21 | |
| CFR§ 74.3045 | ||
| USP Sizes | USP 2-0 | 4/0 to 1 |
| Needle Shape | Straight | 1/2 circle, 3/8 circle, 5/8 circle, "ski" |
| needle, Straight | ||
| Needle Cross | ||
| Section | Cylindrical | Cylindrical, Triangular, Trapezoidal |
| Needle Material | 420B stainless steel | Surgical stainless steel: AISI 470, AISI |
| 455, AISI 301, AISI 302, AISI 304, AISI | ||
| 304L, AISI 31,6 AISI 320, AISI 321, | ||
| Cobalt chromium | ||
| Single Use | Yes | Yes |
| Sterile | Yes, EO Sterilization, SAL 10-6 | Yes, EO Sterilization, SAL 10-6 |
| Complies with | ||
| USP, | ||
| USP, | ||
| USP | Yes | Yes |
| Biocompatible | Biocompatible in accordance with | |
| ISO 10993-1 and FDA Guidance | Biocompatible in accordance with ISO | |
| 10993-1 and FDA Guidance |
Device Comparison Table:
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6
7. PERFORMANCE DATA
Biocompatibility
Biocompatibility testing was performed in accordance with ANSVAAMI/ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process, as well as FDA's 2016 guidance document "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Specific testing included the following:
- . Cytotoxicity, ISO 10993-5
- Sensitization, ISO 10993-10
- Irritation, ISO 10993-10
- . Acute systemic Toxicity, ISO 10993-11
- Materials Mediated Pyrogenicity, ISO 10993-11
- Implantation, ISO 10993-6
- Hemocompatibility, ISO 10993-4, ASTM F756-17 ●
- Subchronic Toxicity, 90-day Subchronic Intramuscular Implantation, ISO 10993-11
- Genotoxicity, Ames Bacterial Reverse Mutation Assay, OECD 471
- Genotoxicity: In Vivo Mouse Micronucleus Mutagenicity Assay, OECD 487
- Genotoxicity: Mouse Lymphoma Assay, OECD 476
- Bacterial Endotoxin Test, USP
Bench Testing
Physical testing was performed to establish compliance with:
- . USP suture diameter
- USP suture attachment
- USP tensile strength
Ex-vivo tissue holding strength testing was conducted compared to the predicate to demonstrate substantially equivalent tissue holding strength.
Ethylene Oxide sterility validation testing was conducted in accordance with overkill half-cycle methods per ISO 11135:2014 to demonstrate SAL 10°. Residuals were evaluated in accordance with ANSI/AAMI/ISO 10993-7:2008/(R) 2012.
Shelf life testing involved package integrity and seal strength testing subsequent to environmental preconditioning and distribution simulation, in accordance with AAMI/ISO 11607-1: 2006 (R) 2010, ASTM D4169-16, ASTMF88/F88M-15, and ASTM F2096-11.
7
Animal Study
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Study
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSIONS 8.
The technological features of the APTOS Threads – Polypropylene Surgical Sutures are very similar to the predicate device, as both devices are constructed of dyed polypropylene, and may have divergent bi-directional barbs, with smooth sections in the middle and next to the introductory needles. Testing was conducted to demonstrate that the APTOS Threads -Polypropylene Surgical Sutures are substantially equivalent to the predicates. This included testing to demonstrate that, like the predicates, the APTOS Threads are biocompatible, sterile, have adequate shelf life, meet USP physical testing requirements for sutures, and possess tissue holding strength adequate to approximate tissue. The results of this testing demonstrate that the APTOS Threads - Polypropylene Surgical Sutures are substantially equivalent to the predicate devices.