(346 days)
Not Found
No
The document describes a physical membrane for tendon repair and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for "management and protection of tendon injuries," which addresses a medical condition or disease.
No
This device is a protective membrane for tendon injuries, not a diagnostic tool. Its purpose is management and protection (treatment), not identification or assessment of a medical condition.
No
The device description clearly states it is a physical, absorbable fibrous membrane made of polymers, provided in various sizes, and is a single-use, sterilized, porous, polymeric membrane. This indicates it is a 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 for the "management and protection of tendon injuries." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a "fibrous membrane" used as a "protective layer between the injured tissue and surrounding tissues." This describes a physical barrier or support, not a test performed on biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on tissue response, resorption, and equivalence to predicate devices used for tissue repair, not diagnostic accuracy.
In vitro diagnostics are tests performed outside the body on biological samples to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is applied within the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Product codes (comma separated list FDA assigned to the subject device)
OWW, FTL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendon injuries
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 test:
The company conducted mechanical strength testing, biocompatibility testing, and an in vivo animal study.
- Mechanical strength: Testing was conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 1999) to demonstrate substantial equivalence.
- 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 management process. This demonstrated that the device is substantially equivalent to its predicate and is biocompatible.
- In vivo animal study: The 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.
Key results: The results of the mechanical performance, biocompatibility and animal efficacy testing demonstrated that SpinMedix® Absorbable Fibrous Membrane is substantially equivalent to its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Surgi-Wrap MAST Tendon Sheet, K063648, TAPESTRY® Biointegrative Implant, K201572
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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".
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
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,
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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Image /page/3/Picture/1 description: The image is a logo with a circular shape that transitions from yellow at the top to red at the bottom. Inside the circle, there is a stylized design featuring a curved road or path in a gradient of orange and red. Behind the road, there is a sun-like burst of rays, also in shades of orange and yellow, suggesting warmth and brightness. The overall design conveys a sense of travel, adventure, or forward movement, possibly related to transportation or outdoor activities.
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. Han |
| General 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, Surgical |
| 878.3300 | |
| Class II | |
| OWW, FTL | |
| Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Predicate Device(s) | Surgi-Wrap MAST Tendon Sheet, K063648 |
| MAST Biosurgery Inc. San Diego, CA | |
| TAPESTRY® Biointegrative Implant, K201572 | |
| Embody, 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® Absorbable | ||
| Fibrous Membrane | MAST Biosurgery Surgi- | ||
| Wrap MAST Tendon | |||
| Sheet (K063648) | TAPESTRY | ||
| Biointegrative Implant | |||
| (K201572) | |||
| 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. | The Surgi-Wrap MAST | ||
| Tendon Sheet is | |||
| indicated for the | |||
| management and | |||
| protection of tendon | |||
| injuries in which there | |||
| has been no substantial | |||
| loss of tendon tissue. | |||
| The resorbable | |||
| Protective Film | |||
| minimizes tissue | |||
| attachment to the device | |||
| in case of direct contact | |||
| with the tissues. | |||
| The Surgi-Wrap MAST | |||
| Tendon Sheet is also | |||
| indicated for | |||
| reinforcement of soft | |||
| tissues repaired by suture | |||
| or suture anchors, during | |||
| tendon repair surgery, | |||
| including reinforcement | |||
| of the rotator cuff, | |||
| patellar, Achilles, biceps, | |||
| quadriceps, or other | |||
| tendons. Surgi-Wrap | |||
| MAST Tendon Sheet is | TAPESTRY® is | ||
| indicated for the | |||
| management and | |||
| protection of tendon | |||
| injuries in which there | |||
| has been no substantial | |||
| loss 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 | |
| Resorbable | |||
| Material | Yes | Yes | |
| Sterilization | Ethylene Oxide to SAL of 10-6 | eBeam Irradiation to SAL of 10-6 | |
| Pyrogenicity | Non-pyrogenic | ||
| ( |