(175 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a barbed suture, with no mention of AI or ML.
Yes
The device is described as an absorbable surgical suture indicated for soft tissue approximation, which directly implies a medical purpose for treating or preventing disease/injury.
No
The device description clearly states its purpose is "soft tissue approximation," which means it physically holds tissues together. This is a therapeutic action, not a diagnostic one. Diagnostic devices are used to detect or identify a condition or disease.
No
The device description clearly states it is a physical surgical suture made of poly(p-dioxanone) with barbs and potentially a stainless steel needle. It is a tangible, physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture, designed to physically hold tissue together.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing biological samples outside the body. This device is a surgical tool used within the body.
N/A
Intended Use / Indications for Use
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Product codes
NEW
Device Description
The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2.
The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots.
The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight.
The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- USP 42-NF 37:2019 Absorbable Surgical Suture
- USP 42-NF 37:2019 Bacterial Endotoxins Limit;
- USP 42-NF 37:2019 Sterility Test
- USP 42-NF 37:2019 Sutures - Diameter
- USP 42-NF 37:2019 Sutures - Needle Attachment
- USP 42-NF 37:2019 Tensile Strength
- ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
- ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
- ISO 10993-11:2017 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 [Including: Amendment 1 (2018)]
- ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
- ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Real time Aging (three years).
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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 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.
October 20, 2020
Foosin Medical Supplies Inc., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 China
Re: K201139
Trade/Device Name: WEGO-PDO Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: September 15, 2020 Received: September 17, 2020
Dear Diana Hong:
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
1
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,
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) K201139
Device Name WEGO-PDO Barbed Suture
Indications for Use (Describe)
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201139
-
- Date of Preparation: 10/9/2020
-
- Sponsor Identification
Foosin Medical Supplies Inc., Ltd. No.20, Xingshan Road, Weihai Torch Hi-tech Science Park, Weihai, Shandong, 264210, China
Establishment Registration Number: 3006562124
Contact Person: Zhipeng Yang Position: President of Technology Tel: +86-631-5660576 Fax: +86-631-5621680 Email: Foosin-ce@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: WEGO-PDO Barbed Suture Common Name: Absorbable Polydioxanone Surgical Suture Size: USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2
- Identification of Proposed Device
Regulatory Information Classification Name: Absorbable polydioxanone surgical suture Classification: II
4
Product Code: NEW Regulation Number: CFR 878.4840 Review Panel: General & Plastic Surgery
Indications for Use:
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2.
The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots.
The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight.
The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K113744 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) Manufacturer: Angiotech
Predicate Device 2 510(k) Number: K120827 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone)
5
Manufacturer: Angiotech
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
USP 42-NF 37:2019 Absorbable Surgical Suture
-
USP 42-NF 37:2019 Bacterial Endotoxins Limit; >
-
USP 42-NF 37:2019 Sterility Test >
-
USP 42-NF 37:2019 Sutures - Diameter
-
USP 42-NF 37:2019 Sutures - Needle Attachment
-
USP 42-NF 37:2019 Tensile Strength
-
ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
-
ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
-
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
-
ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
-
ISO 10993-11:2017 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 [Including: Amendment 1 (2018)]
-
ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
-
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
-
ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Real time Aging (three years)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
8. Substantially Equivalent (SE) Comparison
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 | Remark | ||
|---|---|---|---|---|---|---|
| Product Code | NEW | K113744 | K120827 | SE | ||
| Regulation Number | CFR 878.4840 | CFR 878.4840 | CFR 878.4840 | SE | ||
| Class | II | II | II | SE | ||
| Indications for Use | WEGO-PDO Barbed Suture is | |||||
| indicated for soft tissue | ||||||
| approximation where use of an | ||||||
| absorbable suture is appropriate. | QuillTM PDO Knotless Tissue-Closure | |||||
| Device, comprised of Polydioxanone, | ||||||
| is indicated for soft tissue | ||||||
| approximation where use of an | ||||||
| absorbable suture is appropriate. | QuillTM PDO Knotless | |||||
| Tissue-Closure Device, comprised of | ||||||
| Polydioxanone, is indicated for soft | ||||||
| tissue approximation where use of an | ||||||
| absorbable suture is appropriate. | SE Analysis | |||||
| 1 | ||||||
| Configuration | Suture and Needle | Suture and Needle | Suture and Needle | SE | ||
| Welded Loop | Manufacture | |||||
| Method | ||||||
| Purpose | ||||||
| Length | Ultrasonically | |||||
| welded | ||||||
| a basic fixation | ||||||
| loop and secure | ||||||
| the fixation loop | ||||||
| portion to robust | ||||||
| tissue | ||||||
| 10mm | Manufacture | |||||
| Method | ||||||
| Purpose | ||||||
| Length | Ultrasonically | |||||
| welded | ||||||
| help to form a | ||||||
| secondary | ||||||
| variable loop and | ||||||
| secure the device | ||||||
| at the distal end | ||||||
| 10mm | N/A | SE | ||||
| Analysis 2 | ||||||
| Sterility | EO Sterilized | EO Sterilized | EO Sterilized | SE | ||
| SAL | $1.0×10^{-6}$ | $1.0×10^{-6}$ | $1.0×10^{-6}$ | SE | ||
| Single Use | Yes | Yes | Yes | SE | ||
| SUTURE | ||||||
| Material | poly (p-dioxanone) | poly (p-dioxanone) | poly (p-dioxanone) | SE |
7
| Color | Undyed; dyed violet with D&C
Violet No.2 | dyed violet with D&C Violet No.2 | dyed violet with D&C Violet No.2 | SE
Analysis 3 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------|
| Absorbable /
Non-absorbable | Absorbable | Absorbable | Absorbable | SE |
| Braided /
Monofilament | Monofilament | Monofilament | Monofilament | SE |
| Type of barbs | Uni-directional,
Bi-directional | Uni-directional, | Bi-directional | SE
Analysis 4 |
| Suture Size | USP 5-0, USP 4-0, USP 3-0,
USP 2-0, USP 0, USP 1, USP 2 | USP 0 | USP 4-0, USP 3-0, USP 2-0, USP 0,
USP 1, USP 2 | SE
Analysis 5 |
| Suture Length | Models of uni-directional
barb :15cm, 20 cm, 30 cm, 45
cm, 60 cm, 70 cm
Models of bidirectional
barb :77 cm, 1010 cm, 1414
cm, 1818cm, 2424 cm, 3030
cm,3636 cm, 4040 cm, 4545
cm | 20 cm, 30 cm, 45 cm | 77 cm, 1010 cm, 1414 cm,
1616cm, 2424 cm, 3030m,
3636 cm | SE
Analysis 6 |
| Diameter of Suture | The suture diameters of
proposed device comply with
the diameter requirement listed
in USP Diameter. | The suture diameters of
proposed device complies with the
diameter requirement listed in USP
Diameter. | The suture diameters of
proposed device complies with the
diameter requirement listed in USP
Diameter. | SE |
| Tensile Strength | The tensile strengths of
proposed device comply with
the tensile requirement listed in
USP Tensile Strength | The tensile strengths of
proposed device complies with the
tensile requirement listed in USP
Tensile Strength | The tensile strengths of
proposed device complies with the
tensile requirement listed in USP
Tensile Strength | SE |
| Needle Attachment | | | | |
| | The bond between suture and
needle of the applicant device
meet the requirements defined
in USP . | The bond between suture and
needle of the applicant device
meet the requirements defined
in USP .
NEEDLE | The bond between suture and
needle of the applicant device
meet the requirements defined
in USP . | SE |
| | | | | |
| Cytotoxicity | No cytotoxicity. | The specific test items are unknown.
However, the product should meet the | The specific test items are unknown.
However, the product should meet | SE |
| Max Sensitization | No skin sensitization. | requirements of ISO10993 series
standards. | the requirements of ISO10993 series
standards. | Analysis 7 |
| Intracutaneous
Reactivity Test | No intracutaneous reactivity. | SUTURE | | |
| | | | | |
| Cytotoxicity | No cytotoxicity. | | | |
| Max Sensitization | No skin sensitization. | | | |
| Intracutaneous
Reactivity Test | No intracutaneous reactivity. | | | |
| Acute Systemic
Toxicity Test | No systemic toxicity. | | The specific test items are unknown.
However, the product should meet
the requirements of ISO10993 series
standards. | SE
Analysis 8 |
| Genotoxicity | No genotoxicity. | The specific test items are unknown. | | |
| Pyrogenicity | No potential febrile reaction. | However, the product should meet the | | |
| Muscle Implantation
Study | No reaction to the tissue. | requirements of ISO10993 series
standards. | | |
| Sub chronic
Toxicity Study | No systemic toxicity. | | | |
| Hemolysis Test
(Direct Contact) | No Hemolysis | | | |
| Hemolysis Test
(Indirect Contact) | No Hemolysis | | | |
8
9
SE Analysis 1 - Indications for Use
The indications for use of Predicate device 1 and Predicate device 2 includes the material (Polydioxanone) of suture. Although the indications for use of Proposed Device does not include the material of suture, the suture's material of Proposed Device is also Polydioxanone. Therefore, this item is considered to be substantially equivalent.
SE Analysis 2- Welded Loop
The manufacture method and length of proposed device's and predicate device's welded loop are same. Although the purpose of proposed device's and predicate device's welded loop is different, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.
SE Analysis 3- Color
The suture of Predicate Device 1 and Predicate Device 2 is dyed. The suture of Proposed Device is available in undyed and dye. The color of Proposed Device 1 and Predicate Device 1 and Predicate Device 2's suture is dyed with D&C Violet No. 2. The Proposed Device has more undyed suture than the Predicate Device 1 and Predicate Device 2. The test reports for the undyed suture of Proposed Device provided in this submission, including performance test, and stability demonstrates that the undyed Proposed Device complied with the requirements of USP Absorbable Surgical Suture. Therefore, this item is considered to be substantially equivalent.
SE Analysis 4- Type of barbs
The barbs of Proposed Device include uni-directional barb and bi-directional barbs. The uni-directional barb of Proposed Device is same with the barb of Predicate Device 1. The bi-directional barb of Proposed Device is same with the barb of Predicate Device 2. Therefore, this item is considered to be substantially equivalent.
SE Analysis 5- Suture Size
The suture sizes of Proposed Device and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although the range of suture size of Proposed Device is more than that of the Predicate Device 2, the suture sizes of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.
SE Analysis 6- Suture Length
The requirements for suture length of Proposed Device and Predicate Device 1 and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although we do not know the exact suture length of Predicate Device 1 and Predicate Device 2, the suture lengths of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent.
SE Analysis 7- Needle Biocompatibilitv
10
The needle biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 are should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, but the needle biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Sensitization and Intracutaneous Reactivity Test. These studies can demonstrate the needle biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.
SE Analysis 8- Suture Biocompatibility
The biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, the biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Genotoxicity, Pyrogenicity, Muscle Implantation Study, Sub chronic Toxicity Study, Hemolysis Test (Direct Contact) and Hemolysis Test (Indirect Contact). These studies can demonstrate the biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.