(1139 days)
TisuthesTM e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery.
Tisuthes™ e-PTFE Surgical Patches are intended for facial plastic and reconstruction surgery. The device is provided sterile. The device is available in the forms of sheets, blocks and preformed three-dimensional forms (chin, nasal, temporal piriform and malar) with multiple sizes.
The provided FDA 510(k) summary (K201153) describes a medical device, the Tisuthes™ e-PTFE Surgical Patch, and aims to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the kind of detailed performance study information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods.
This 510(k) submission primarily focuses on comparing the proposed device's characteristics (indications for use, materials, design, shapes, physical dimensions, pore size, sterilization) with those of legally marketed predicate devices. The "Non-Clinical Tests Performed" section lists various ISO and ASTM standards, which are general biocompatibility and material testing standards, not performance studies as typically understood in the context of AI/medical image analysis or diagnostic devices.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided text. The document states that the proposed device is "determined to be Substantially Equivalent (SE) to the predicate devices" based on similar classification information, specifications, and performance effectiveness, but it does not provide the underlying data or studies to support this "performance effectiveness" claim in the detailed format you've requested.
Here's why the information is missing:
- Type of Device: The Tisuthes™ e-PTFE Surgical Patch is a physical implant (surgical mesh). The requested criteria (e.g., accuracy, sensitivity, specificity, MRMC studies) are typically relevant for diagnostic devices, AI algorithms, or imaging systems, not for physical implants like surgical patches.
- Regulatory Pathway: A 510(k) submission demonstrates "substantial equivalence" to a predicate device, meaning it is as safe and effective as a legally marketed device. This often relies on comparative data for material properties, biocompatibility, and intended use, rather than a de novo clinical trial with defined acceptance criteria for a new diagnostic performance metric.
- Focus of the Document: The document's purpose is to satisfy the 510(k) requirements by showing how the new device is substantially equivalent to existing ones. It does not present new efficacy or performance study data in the way a PMA (Premarket Approval) submission or an AI/diagnostic device submission might.
In summary, the provided text does not contain the information needed to create the table and answer the questions about acceptance criteria, study design, expert involvement, and ground truth establishment for a performance study.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 13, 2023
Shanghai Suokang Medical Implants Co., Ltd. Lixinhua Lixinhua Deputy General Manager Building 2, No. 613, Suide Rd., Putuo Region, Shanghai, 200311. P.R. China Shanghai, Shanghai 200000 China
Re: K201153
Trade/Device Name: Tisuthes e-PTFE Surgical Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWR, FTL Dated: Mav 22, 2021 Received: May 27, 2021
Dear Lixinhua Lixinhua:
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
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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 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 (OS) 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,
David Krause -S
David Krause, Ph.D. Deputy Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201153
Device Name TisuthesTM e-PTFE Surgical Patch
Indications for Use (Describe)
TisuthesTM e-PTFE Surgical Patches are indicated for facial plastic and reconstructive surgery.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5 - 510(k) Summary
Date of Summary Preparation: 2020.11.19
1. Submitter's Identifications
Submitter's Name: Shanghai Suokang Medical Implants Co., Ltd. Address: Building 2, No. 613, Suide Rd., Putuo District,Shanghai,China
Contact Person: Lixinhua Contact Email: surgithes@vip.sina.com
Phone number: +86 21 6608 2766 ext.812
Fax number: +86 66082138
2. Correspondent's Identifications
Correspondent's Name: Shanghai Suokang Medical Implants Co., Ltd. Address: Building 2, No. 613, Suide Rd., Putuo District, Shanghai,China Contact Person: Lixinhua Contact Email: surgithes@vip.sina.com Phone number: +86 21 6608 2766 ext.812 Fax number: +86 66082138
3. Name of the Device
Device Classification Name: Mesh, Surgical, Polymeric Product Code: FTL , OWR
Product Name: Tisuthes™ e-PTFE Surgical Patch Trade Name: Tisuthes™ e-PTFE Surgical Patch Common Name: Surgical mesh Classification Panel: General & Plastic Surgery Product Code: FTL , OWR Device Classification: Class II
4. The Predicate Devices
Trade/Device Name: Surgiform Augmentation Material
Trade/Device Name: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
5. Device Description
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5.1 Tisuthes™ e-PTFE Surgical Patches are intended for facial plastic and reconstruction surgery. The device is provided sterile.
The device is available in the forms of sheets, blocks and preformed three-dimensional forms (chin, nasal, temporal piriform and malar) with multiple sizes.
5.2. Symbol
TP: Expanded Polytetrafluoroethylene (e-PTFE) Surgical Patch (Brand Name:
Tisuthes)
5.3 Product numbers definition
5.3.1 Marking method
TP:
Image /page/4/Figure/9 description: The image shows a diagram with labels for different codes. The top line is labeled "Serial number" and is connected to "X...XX". The middle line is labeled "Category number" and is connected to "X". The bottom line is labeled "Product code" and is connected to "TP".
Category number: S: Soft Patch
R: Block
N: Nasal implants
C: Chin implants
M: Malar implants
F: Piriform implants
T: Temporal implants
5.4 Model and Specification
| Spc. | a(mm) | b(mm) | c(mm) | d(mm) | Tolerance | Diagram |
|---|---|---|---|---|---|---|
| TPS01 | 60 | 40 | 1 | / | ±10% | Image: Diagram of a soft patch |
| TPS02 | 60 | 40 | 2 | / | ±10% | |
| TPS03 | 60 | 40 | 3 | / | ±10% | |
| TPS04 | 60 | 40 | 4 | / | ±10% | |
| TPS05 | 80 | 60 | 1 | / | ±10% | |
| TPS06 | 80 | 60 | 2 | / | ±10% | |
| TPS07 | 80 | 60 | 3 | / | ±10% | |
| TPS08 | 80 | 60 | 4 | / | ±10% |
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| TPS09 | 140 | 60 | 1 | / | ±10% | |
|---|---|---|---|---|---|---|
| TPS10 | 140 | 60 | 2 | / | ±10% | |
| TPS11 | 140 | 60 | 3 | / | ±10% | |
| TPS12 | 140 | 60 | 4 | / | ±10% | |
| Block (TPR) | ||||||
| a(mm) | b(mm) | c(mm) | d(mm) | Tolerance | ||
| Spc. | Diagram | |||||
| TPR01 | 70 | 20 | 5 | / | ±10% | |
| TPR02 | 70 | 20 | 8 | / | ±10% | |
| TPR03 | 60 | 50 | 3 | / | ±10% | |
| TPR04 | 60 | 40 | 5 | / | ±10% | |
| TPR05 | 70 | 15 | 8 | / | ±10% | |
| TPR06 | 70 | 15 | 6 | / | ±10% | |
| TPR07 | 70 | 15 | 5 | / | ±10% | |
| TPR08 | 100 | 50 | 5 | / | ±10% | |
| TPR09 | 100 | 50 | 8 | / | ±10% | |
| Nasal implants (TPN) | ||||||
| Spc. | a(mm) | b(mm) | c(mm) | d(mm) | Tolerance | Diagram |
| TPN11 | 55 | 16 | 5.5 | 20 | ±10% | |
| TPN12 | 65 | 11 | 5 | 20 | ±10% | |
| TPN13 | 55 | 11 | 5 | 20 | ±10% | |
| TPN14 | 55 | 11 | 6.5 | 20 | ±10% | |
| TPN15 | 50 | 12 | 5 | 10 | ±10% | |
| TPN16 | 50 | 12 | 6.5 | 10 | ±10% | |
| TPN17 | 60 | 12 | 5 | 10 | ±10% | |
| Chin implants (TPC) | ||||||
| Spc. | a(mm) | b(mm) | c(mm) | d(mm) | Tolerance | Diagram |
| TPC01 | 55 | 40 | 8 | 15 | ±10% | |
| TPC02 | 55 | 40 | 12 | 15 | ±10% | |
| TPC03 | 55 | 40 | 10 | 15 | ±10% | Image: Diagram of a lens with labels a, b, c, and d |
| TPC04 | 60 | 25 | 8 | 15 | ±10% | Image: Diagram of a lens with labels a, b, c, and d |
| TPC05 | 60 | 25 | 10 | 15 | ±10% | Image: Diagram of a lens with labels a and d |
| TPC06 | 55 | 40 | 8 | 15 | ±10% | Image: Diagram of a lens with labels b and c |
| TPC07 | 62 | 42 | 8 | 15 | ±10% | |
| TPC08 | 62 | 42 | 10 | 15 | ±10% | Image: Diagram of a lens with labels a and d |
| TPC09 | 60 | 40 | 8 | 15 | ±10% | Image: Diagram of a lens with labels a, b, c, and d |
| TPC10 | 50 | 18 | 5.5 | 15 | ±10% | Image: Diagram of a lens with labels a, b, c, and d |
| TPC11 | 42 | 10 | 5 | 15 | ±10% | Image: Diagram of a lens with labels a, c, and d |
| TPC12 | 55 | 28 | 8 | 15 | ±10% | |
| TPC13 | 55 | 28 | 10 | 15 | ±10% | |
| TPC14 | 55 | 28 | 12 | 15 | ±10% | Image: Diagram of TPC14 |
| TPC15 | 60 | 28 | 8 | 15 | ±10% | Image: Diagram of TPC15 |
| TPC16 | 60 | 28 | 10 | 15 | ±10% | Image: Diagram of TPC16 |
| TPC17 | 60 | 28 | 12 | 15 | ±10% | Image: Diagram of TPC17 |
| Malar implants(TPM) | ||||||
| Spc. | a (mm) | b (mm) | c (mm) | d (mm) | Tolerance | Diagram |
| TPM01 | 60 | 28 | 5 | / | ±10% | Image: Diagram of TPM01 |
| TPM02 | 60 | 28 | 5 | / | ±10% | Image: Diagram of TPM02 |
| Piriform Implants (TPF) | ||||||
| Spc. | a (mm) | b (mm) | c (mm) | d (mm) | Tolerance | Diagram |
| TPF01 | 25 | 22 | 5 | / | ±10% | Image: Diagram of TPF01 |
| TPF03 | 25 | 22 | 8 | / | ±10% | Image: Diagram of TPF03 |
| TPF02 | 25 | 22 | 5 | / | ±10% | Image: Diagram of TPF02 |
| TPF04 | 25 | 22 | 8 | / | ±10% | Image: Diagram of TPF04 |
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6. Intended Use of Device
Tisuthes™ e-PTFE Surgical Patches are intended for facial plastic and reconstruction surgery.
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7. Summary of Substantial Equivalence
| Product | Proposed device | Predicate device | Predicate device | |
|---|---|---|---|---|
| TisuthesTM ePTFE Surgical Patch K201153 | Surgiform Augmentation Material K021889 | Surgiform's PureForm ePTFE Impants K091011 | ||
| Indication for use | TisuthesTM e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery. | For Plastic and Reconstructive Surgery. | PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery. | |
| Contraindications | Cardiovascular defects Tempormandibular joint (TMJ reconstructions) Cosmetic lip filler Dermal placement | Cardiovascular defects Tempormandibular joint (TMJ reconstructions) Cosmetic lip filler Dermal placement | Tempormandibular joint (TMJ reconstructions) Dermal placement | |
| Material | e-PTFE | e-PTFE | e-PTFE | |
| Design principle | Augmentation or repair of the soft tissue | Augmentation or repair of the soft tissue | Augmentation or repair of the soft tissue | |
| Shapes | The device is available in the forms of sheets, blocks, and preformed three-dimensional forms (chin, nasal, temporal piriform and malar) with multiple sizes. | Flat sheets and Carvable block | Pre-formed 3-D shapes (chin, nasal, malar and para-nasal) in multiple sizes. | |
| Physical characteristics | Dimension (mm) | Sheets:Length: 60, 80,140;Width: 40, 60;Thickness: 1, 2, 3, 4.Blocks:Length: 60, 70, 100;Width: 15, 20, 40, 50; | Sheets:Length: 80, 190;Width: 30, 70, 170;Thickness: 0.35, 1, 2, 3.Blocks:Length: 60, 70;Width: 15, 30, 50, 100; |
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| Thickness: 3, 5, 6, 8. | Thickness: 5, 6, 8, 10. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Nasal implants[1]: (TPN11~TPN17) | ASIAN STRAIGHT NASAL DORSUM | |||||||||
| a: 50, 55, 60; | ItemCode | Dim A(mm) | Dim B(mm) | Dim C(mm) | Dim D(mm) | |||||
| b: 11, 12, 16; | 4AND03 | 50.0 | 7.5 | 9.5 | 4.0 | |||||
| c: 5, 5.5,6.5; | 4AND04 | 50.0 | 8.0 | 10.0 | 4.0 | |||||
| d: 10, 20. | 5AND02 | 50.0 | 7.5 | 9.5 | 5.0 | |||||
| 6AND02 | 50.0 | 8.0 | 10.0 | 6.0 | ||||||
| ASIAN CURVED NASAL DORSUM | ||||||||||
| ItemCode | Dim A(mm) | Dim B(mm) | Dim C(mm) | Dim D(mm) | ||||||
| 4AND01 | 50.0 | 9.5 | 7.5 | 4.0 | ||||||
| 4AND02 | 50.0 | 10.0 | 8.0 | 4.0 | ||||||
| 5AND01 | 50.0 | 9.5 | 7.5 | 5.0 | ||||||
| 6AND01 | 50.0 | 10.0 | 8.0 | 6.0 | ||||||
| Chin implants: | CHIN IMPLANTS | |||||||||
| a: 42, 55, 60, 62; | ItemCode | Dim A(mm) | Dim B(mm) | Dim C(mm) | Dim D(mm) | |||||
| b: 10, 18, 25, 28, 40, 42; | 1EC01 | 52.9 | 38.1 | 7.7 | 13.5 | |||||
| c: 5, 5.5, 8, 10, 12; | 1EC02 | 59.3 | 42.9 | 8.2 | 14.8 | |||||
| d: 12. | 1EC03 | 66.0 | 47.4 | 9.5 | 16.9 | |||||
| Malar implants: | MALAR IMPLANTS (RIGHT AND LEFT) | |||||||||
| a: 60; | ItemCode | Dim A(mm) | Dim B(mm) | Dim C(mm) | ||||||
| b: 28; | 1ML01 | 35.0 | 18.0 | 3.5 | ||||||
| c: 5. | 1ML02 | 45.4 | 23.0 | 5.0 | ||||||
| 1ML03 | 49.4 | 24.0 | 5.7 | |||||||
| 1ML04 | 55.0 | 27.1 | 5.8 | |||||||
| Piriform implants | ASIAN PARA-NASAL | |||||||||
| a: 25; | ItemCode | Dim A(mm) | Dim B(mm) | Dim C(mm) | ||||||
| b: 22; | 4PN01 | 20.0 | 18.0 | 4.0 | ||||||
| c: 5, 8. | 5PN01 | 20.0 | 18.0 | 5.0 | ||||||
| 6PN01 | 21.0 | 19.0 | 6.0 | |||||||
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| Pore Size (microns) | >15 | 20-40 | 20-40 |
|---|---|---|---|
| Provided sterile | Yes | Yes | Yes |
| Re-sterilization | Not recommended | May be sterilized up to 3 times | May be sterilized up to 3 times |
8. Substantial Equivalence:
Substantial Equivalence discussion:
The proposed devices and the predicated device the same classification information, same specifications, same performance effectiveness. The Model of Proposed Device is included in the Model of Predicate for use of proposed device is included in the predicated devices are as safe, as effective and perform as well as the predicate device. Therefore the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
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9. Non-Clinical Tests Performed:
- A F754-08 (Reapproved 2015) Standard Specification For Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, And Rod Shapes Fabricated From Granular Molding Powders
-
F881-94 (Reapproved 2014) Standard Specification For Silicone Elastomer Facial Implants
-
ISO 14630 Fourth Edition 2012-12-01 Non-Active Surgical Implants -- General Requirements
-
ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical Devices -Part 1: Evaluation And Testing Within A Risk Management Process
-
ISO 10993-3 Third Edition 2014-10-1 Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity And Reproductive Toxicity
-
ISO 10993-4 Third Edition 2017-04 Biological Evaluation Of Medical Devices--Part 4: Selection Of Tests For Interactions With Blood
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ISO10993-5 Third Edition 2009-06-01 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-6 Third Edition 2016-12-01 Biological Evaluation Of Medical Devices -- Part 6: Tests For Local Effects After Implantation
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ISO 10993-7:2008(R)2012 Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
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ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ISO 10993-11 Third Edition 2017-09 Biological Evaluation Of Medical Devices -Part 11: Tests For Systemic Toxicity
-
ISO 11135:2014 Sterilization Of Health-Care Products - Ethylene Oxide -Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
10. Conclusion:
The proposed devices of Tisuthes™ e-PTFE Surgical Patch are determined to be Substantially Equivalent (SE) to the predicate devices.
--- End of this section ---
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.