(378 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a surgical suture, with no mention of AI or ML capabilities.
No.
The device is a surgical suture used for approximation of soft tissue; it aids in the healing process but does not directly treat a disease or condition as a therapeutic device would.
No
Explanation: The device description clearly states that OPTIME®R sutures are "used in suturing when short-term support and rapid strength loss are needed." This indicates a therapeutic or surgical function, not a diagnostic one. Diagnostic devices are used to identify the presence, nature, or cause of a disease or condition. This device is used for treatment (suturing), not diagnosis.
No
The device description clearly describes a physical medical device (sutures and needles) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states that OPTIME® R sutures are used for "suturing in open or laparoscopic surgery." This involves physically joining tissues within the body.
- Intended Use: The intended use is for "general soft tissue approximation," which is a surgical procedure performed on the body.
- No Mention of Samples or Testing: The description does not mention collecting samples, performing tests on those samples, or providing diagnostic information based on such tests.
Therefore, based on the provided information, OPTIME® R sutures are a surgical device used for tissue repair in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
Product codes
GAM
Device Description
OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery.
These sutures are available with a disposable needle attachment.
OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue approximation, including ophthalmic procedures.
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
As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures.
Testing included:
- Diameter following USP 43
- Tensile strength following USP 43
- Needle attachment following USP 43
- . Length following USP 43- Absorbable surgical suture
Stability testing has been completed.
Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures and is substantially equivalent to its predicate device.
The biological evaluation of OPTIME®R was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:
- Cytotoxicity
- Sensitization
- Irritation
- Material mediated pyrogenicity
- Acute Systemic Toxicity
- Sub-acute/sub-chronic Toxicity
- Genotoxicity
- Chemical characterization and toxicological risk assessment
- Implantation
- Degradation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 11, 2024
Peters Surgical Vikram Verma Regulatory Consultant for Peters Surgical Immeuble AURELIUM. 1 course de 1'lle Seguim Boulogne-Billancourt, Hauts-De-Seine 92100 France
Re: K233265
Trade/Device Name: Optime® R Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: September 12, 2024 Received: September 13, 2024
Dear Vikram Verma:
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. Digitally signed by Tek N. Lamichhane -S Lamichhane - Date: 2024.10.11 S 16:05:30 -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) K233265
Device Name OPTIME® R
Indications for Use (Describe)
OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Abbreviated 510(k) Summary- K233265
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of OPTIME®R Device.
1. Applicant:
PETERS SURGICAL Immeuble Aurélium, 1 Cours de l'Ile Seguin, 92100 Boulogne-Billancourt France
2. Official Correspondent
Marie Compagnon Riobé Immeuble Aurélium 1 cours de l'Ile Seguin 92100 Boulogne-Billancourt, France Phone : +33 1 48 10 62 23 Email : m.compagnon-riobe@peters-surgical.com
3. Regulatory Correspondent/ 510(k) Submission Contact
Vikram Verma Global Regulatory Compliance 240 Annette Ave, Woonsocket, RI 02895 Email: vikver2000@yahoo.com Phone: 978-602-6239
4. Date Prepared: October 11, 2024
5. Device Information:
| Device Trade Name | Common Name | Regulatory Classification | Device Class | Product Code | Panel | Predicate Device |
|---|---|---|---|---|---|---|
| OPTIME®R | Absorbable Surgical | |||||
| Suture, coated | ||||||
| Polyglycolic | ||||||
| Acid braid with | ||||||
| fast resorption | Absorbable | |||||
| Poly(glycolide/l- | ||||||
| lactide) Surgical | ||||||
| Suture (21 CFR | ||||||
| 878.4493) | II | GAM | General | |||
| and | ||||||
| Plastic | ||||||
| Surgery | Safil Quick | |||||
| Aesculap | ||||||
| K031286 |
6. Device Description:
OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery.
These sutures are available with a disposable needle attachment.
5
OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
7. Indication for Use:
OPTIME®R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
8. Comparison of Technological Characteristics
The Absorbable Suture OPTIME®R device is substantially equivalent to the predicate device listed above table in term of intended use, design, performance and principle of operation when compared to the technological characteristics and is available in similar configurations and materials. Below the comparison table specifies substantial equivalence comparison between proposed device and predicate device. Any differences between OPTIME®R suture and it's predicate device are insignificant and do not raise any issues regarding safety or performance of OPTIME®R Surgical Suture.
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OPTIME® R Comparison of technological characteristics to the predicate device:
| Comparative
| Characteristics | Proposed Device : OPTIME® R | Predicate Device: Safil Quick |
|---|---|---|
| 510(k) Number | K233265 | K031286 |
| Classification | General and Plastic Surgery | General and Plastic Surgery |
| Device | ||
| Description | OPTIME® R device is an absorbable | |
| synthetic surgical implantable | ||
| suture. The sutures are undyed, | ||
| sterile comprised of rapidly | ||
| resorbing coated polyglycolic acid | ||
| braid. | Safil Quick device is an absorbable, flexible | |
| multifilament suture thread which is supplied | ||
| dyed, undyed, and sterile. It is composed of a | ||
| synthetic polyglycolic acid polymer, and it is | ||
| indicated for soft tissue approximation where | ||
| only short-term wound support is required. | ||
| Product Code | GAM | GAM |
| Indication for | ||
| Use | OPTIME® R synthetic absorbable | |
| surgical sutures are indicated for use | ||
| in general soft tissue approximation, | ||
| including in ophthalmic procedures, | ||
| but not in cardiovascular or | ||
| neurological procedures. | Safil Quick sutures are indicated for use in general | |
| soft tissue approximation, | ||
| including ophthalmic procedures, but not in | ||
| cardiovascular or neurological procedures. | ||
| Regulation | 21 CFR 878.4493 | 21 CFR 878.4493 |
| Regulatory Class | Class II | Class II |
| Single Use | Yes | Yes |
| Principle Device | ||
| Components | ||
| (Sterile, | ||
| Disposable and | ||
| Single Use) | Thread with attached needle | Thread with attached needle |
| Type of Device | ||
| (Material Used) | Absorbable PGA (Polyglycolic acids) | |
| suture | Absorbable PGA (Polyglycolic acids) suture | |
| Biocompatibility | ||
| Requirements | ISO 10993 | ISO 10993 |
| Sterilization | ||
| methods | Gamma | Gamma |
| Technical Features/Design | ||
| Thread material | PGA - Polyglycolic Acid | PGA - Polyglycolic Acid |
| Thread coating | Coating composed of a mixture of | |
| polycaprolactone and calcium | ||
| stearate (≤ 5%) | Polyglyconate coating | |
| Thread size | USP 6/0 to USP 1 | USP 7/0 to USP 2 |
| Thread length | 45 cm to 90 cm | 30 cm to 250 cm |
| Dyeing of thread | Undyed | Undyed |
| Needles | ||
| materials | Stainless Steel (silver or black | |
| colored) | Stainless Steel (silver colored) | |
| Needle coating | Silicone coated | Information not publicly available |
| Needle | ||
| curvatures | 1/2, 3/8, and straight | 1/2, 1/4, 3/8, 5/8, and straight |
| Needle points | Cutting, taper cutting, taper and | |
| extracut | Taper point, reverse cutting, trocar point, cutting, | |
| round, micro-lancet | ||
| Needle length | 11 mm to 50 mm | 6 mm to 51 mm |
| Absorption time | Absorption of the sutures OPTIME® | Absorption of SAFIL® QUICK takes place after |
| R is essentially complete at 42 days | approximately 42 days. | |
| Shelf-life | 5 years | Information not publicly available |
| Ideal storage | Must be stored in its original | |
| packaging, at a temperature below | ||
| 25°C, in a dry place and protected | ||
| from light | Information not publicly available | |
| Package description | 36 devices units per carton box One | |
| device unit is placed in cardboard | ||
| support inside a tear able aluminum | ||
| pouch which is placed inside a | ||
| secondary pouch of paper/PE peel | ||
| pouch | 12 or 36 devices units per box Devices placed in | |
| cardboard support inside a tear able aluminum | ||
| pouch inside a paper/PE peel pouch |
7
8
9. Summary of Testing
As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures.
Testing included:
- Diameter following USP 43
- Tensile strength following USP 43
- Needle attachment following USP 43
- . Length following USP 43- Absorbable surgical suture
Stability testing has been completed.
Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures and is substantially equivalent to its predicate device.
The biological evaluation of OPTIME®R was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:
- Cytotoxicity
- Sensitization
- Irritation
- Material mediated pyrogenicity
- Acute Systemic Toxicity
- Sub-acute/sub-chronic Toxicity
- Genotoxicity
- Chemical characterization and toxicological risk assessment
- Implantation
- Degradation
10. Conclusion
Based on the information provided within this 510(k) submission, Peters Surgical concludes that:
OPTIME®R is substantially equivalent to the predicate device Safil Quick Synthetic Absorbable Surgical Suture (K031286).