(346 days)
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.
It appears you've provided a 510(k) submission document for a medical device called "SpinMedix Absorbable Fibrous Membrane." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria for an AI/CADe system.
The information provided describes:
- Device Name: SpinMedix Absorbable Fibrous Membrane
- Intended Use: Management and protection of tendon injuries where there has been no substantial loss of tendon tissue.
- Composition: Poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol).
- Testing: Mechanical performance, biocompatibility (ISO 10993-1), and an in vivo animal study (calcaneal tendon incision model and inguinal hernia model).
Crucially, this document does NOT describe an AI/CADe system or a study that would require acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" you are asking for, with details like sample size for test/training sets, expert ground truth establishment, MRMC studies, etc., are specific to the validation of diagnostic AI algorithms, not for a physical medical implant like an absorbable fibrous membrane.
Therefore, I cannot extract the requested information from this document because it is not relevant to the type of device and study you are asking about.
To reiterate, the provided document does NOT contain information about:
- A table of acceptance criteria and reported device performance for an AI algorithm.
- Sample sizes for test sets for an AI algorithm or data provenance.
- Number of experts or their qualifications for establishing AI ground truth.
- Adjudication methods for AI ground truth.
- MRMC studies for human readers with/without AI assistance.
- Standalone AI performance.
- Type of ground truth (expert consensus, pathology, outcomes) for AI diagnostics.
- Sample size for a training set for an AI algorithm.
- How ground truth for a training set for an AI algorithm was established.
This document focuses on showing the physical implant is substantially equivalent to existing implants based on design, materials, performance (mechanical), and biological safety (biocompatibility, animal integration/resorption).
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July 6, 2023
CelestRay Biotech Company, LLC Dr. Charles C. Han PO Box 341754 Bethesda, Maryland 20827-1754
Re: K222220
Trade/Device Name: SpinMedix Absorbable Fibrous Membrane Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW, FTL Dated: Mav 24, 2023 Received: May 24, 2023
Dear Charles Han:
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,
Jesse Muir -S
Jesse Muir, PhD Assistant Director DHT6C: Division of Retorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K222220
Device Name SpinMedix Absorbable Fibrous Membrane
Indications for Use (Describe)
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
| 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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CELESTRAY
Biotech company, LLC
5. 510(k) Summary
| Applicant information | |
|---|---|
| Applicant Name: | CelestRay Biotech company, LLC |
| Applicant Address: | PO BOX 341754, BETHESDA, MD 20827-1754 |
| Phone: | 202-808-5668 |
| Fax: | -- |
| Contact Person: | Charles C. HanGeneral Manager and Partner |
| Date Prepared: | Oct 19, 2022 |
| Name of Device | |
| Device Common Name: | Soft Tissue Reinforcement Mesh |
| Device Trade Name: | SpinMedix® Absorbable Fibrous Membrane |
| Device Classification Name: | Mesh, Surgical878.3300Class IIOWW, FTL |
| Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Predicate Device(s) | Surgi-Wrap MAST Tendon Sheet, K063648MAST Biosurgery Inc. San Diego, CATAPESTRY® Biointegrative Implant, K201572Embody, Inc. Norfolk, VA |
Description of the device
SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.
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Indication for Use
The SpinMedix Fibrous Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
| Haracteristic | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Device Name | SpinMedix® AbsorbableFibrous Membrane | MAST Biosurgery Surgi-Wrap MAST TendonSheet (K063648) | TAPESTRYBiointegrative Implant(K201572) |
| Indicationfor Use | The SpinMedix FibrousMembrane is indicatedfor the management andprotection of tendoninjuries in which therehas been no substantialloss of tendon tissue. | The Surgi-Wrap MASTTendon Sheet isindicated for themanagement andprotection of tendoninjuries in which therehas been no substantialloss of tendon tissue.The resorbableProtective Filmminimizes tissueattachment to the devicein case of direct contactwith the tissues.The Surgi-Wrap MASTTendon Sheet is alsoindicated forreinforcement of softtissues repaired by sutureor suture anchors, duringtendon repair surgery,including reinforcementof the rotator cuff,patellar, Achilles, biceps,quadriceps, or othertendons. Surgi-WrapMAST Tendon Sheet is | TAPESTRY® isindicated for themanagement andprotection of tendoninjuries in which therehas been no substantialloss of tendon tissue. |
| not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The Surgi-Wrap MAST Tendon Sheet reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients' own soft tissue. | |||
| Design | Sheets ranging in size from 25mm x 25mm to 200mm x 300mm with thickness of 0.08mm – 0.16mm | Sheets ranging in size from 25mm x 25mm to 500mm x 500mm with thickness of 0.02mm-1.0mm | |
| Material | Poly(D,L-lactide-co-glycolide) and poly (D, L-lactide-b-ethylene glycol) | Poly(L-lactide-co-D,L-lactide) | |
| Appearance | Fibrous membrane with porous structure | Dense film without micropattern | |
| ResorbableMaterial | Yes | Yes | |
| Sterilization | Ethylene Oxide to SAL of 10-6 | eBeam Irradiation to SAL of 10-6 | |
| Pyrogenicity | Non-pyrogenic( < 20EU/device) | Non-pyrogenic | |
| Single Use | Single use only | Single use only |
Summary/ Comparison of Technical Characteristics
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| Packaging | Dry packaged in a high-barrier, double foilpouch with secondarysterile barrier | a Tyvek® pouch and afoil pouch withsecondary sterile barrier | Dry packaged in ahigh-barrier, doublefoil pouch withsecondary sterile barrier |
|---|---|---|---|
| StorageConditions | Store at temperature-4 to 86°F (-20 to 30°C) | Store at controlled roomtemperature 59-86°F(15-30°C) | Room temperature/ ambient |
| ProductCode | OWW, FTL | FTL | OWY |
| CFR Section | 878.3300 | 878.3300 | 878.3300 |
Equivalence to Marketed Products
SpinMedix® Absorbable Fibrous Membrane and its predicates have been characterized for performance with mechanical strength to demonstrate substantial equivalence. Testing was conducted in accordance with to FDA's Guidance for the Preparation of a Premarket Notification Applicationfor a Surgical Mesh (March 1999).
Biocompatibility Testing for SpinMedix® Absorbable Fibrous Membrane including. cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, and genotoxicity satisfied the requirements outlined in ISO 10993- 1 (2009 & 2018) Biological Evaluation of Medical Devices Part 1 : Evaluation and testing within a risk managementprocess, and helped demonstrate that the device is substantially equivalent to its predicate and is biocompatible in accordance to ISO 10993- 1.
The in vivo animal study evaluated local tissue response, systemic toxicity, and the device resorption profile in a clinically relevant tendon model. SpinMedix® Absorbable Fibrous Membrane was found to be completely resorbed between the 16 to 20-week time points with a complete quiescence of the associated inflammatory response. The device was shown to yield favorable results in the calcaneal tendon incision model and inguinal hernia model and supports a determination of substantial equivalence.
Conclusion of Non-clinical test
The results of the mechanical performance, biocompatibility and animal efficacy testing demonstrated that SpinMedix® Absorbable Fibrous Membrane is substantially equivalent to its predicate.
§ 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.