(30 days)
Not Found
No
The description focuses on the material composition and intended use of a resorbable mesh for bone grafting, with no mention of AI or ML technologies.
Yes
The device is intended to fill voids and gaps in the skeletal system and is replaced by host bone during healing, which directly contributes to the restoration of normal bodily function.
No
Explanation: The device is a resorbable mesh bone graft extender intended to fill voids and gaps in the skeletal system. Its function is to aid in healing and bone regeneration, not to diagnose a condition or disease.
No
The device description clearly states it is comprised of a resorbable mesh pouch containing demineralized human cortical bone, indicating it is a physical implant, not software.
Based on the provided information, the Resorbable Mesh Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for filling voids and gaps in the skeletal system and is used with autograft as a bone graft extender. This is a therapeutic and structural application within the body.
- Device Description: The description details a physical implantable device made of a resorbable mesh pouch containing bone material.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. IVDs are typically used to test blood, urine, tissue, or other bodily fluids or substances.
Therefore, the Resorbable Mesh Device falls under the category of a medical device used for surgical and regenerative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.
Product codes
MOV, MBP
Device Description
The Resorbable Mesh Device is comprised of a resorbable mesh pouch containing demineralized human cortical bone in particulate form. The tissue contained in the pouch is supplied to SeaSpine by a CBER-registered, AATB-accredited tissue bank and is procured, screened, tested and processed in accordance with 21 CFR 1271, Current Good Tissue Practices, AATB Standards for Tissue Banking and other standard procedures. The resorbable mesh pouch is knitted from poly(lactic-co-glycolic) acid (PLGA) fibers which have a high glycolide content.
The Resorbable Mesh Device is offered in various sizes and provided in individually sterile packaged units and ready-to-use. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-9.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, posterolateral spine and pelvis
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
Non-clinical testing was not performed on the subject device, as the subject device does not introduce a new worst case, for the following: biocompatibility, bacterial endotoxin, viral inactivation/clearance, osteoinductive potential and in vivo (animal) safety and performance. A sterilization validation was performed and complies with ISO 11137, Sterilization of Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 10-6.
Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Result: The submitted data demonstrate that the Resorbable Mesh Device is substantially equivalent to the cited legally marketed predicate.
Key Metrics
Not Found
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
SeaSpine Orthopedics Corporation Caryn Sailor Manager, Regulatory Affairs 2 Goodyear Irvine, California 92618
Re: K193040
Trade/Device Name: Resorbable Mesh Device Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: October 29, 2019 Received: October 31, 2019
Dear Ms. Sailor:
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.
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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 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 (QS) 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 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-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.
Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, 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) K193040
Device Name Resorbable Mesh Device
Indications for Use (Describe)
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.
| 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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510(k) Summary
Contact Details
| Owner Operator Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Establishment Name: | IsoTis OrthoBiologics, Inc. |
| Address: | 2 Goodyear, Irvine, CA |
| Phone number: | (949) 855-7174 |
| Fax number: | (949) 595-8711 |
| Contact person: | Caryn Sailor, Manager, Regulatory Affairs |
| Email address: | caryn.sailor@seaspine.com |
| Date Prepared: | November 15, 2019 |
| Device Name | |
| Trade Name: | Resorbable Mesh Device |
| Common Name: | Demineralized Bone Matrix Allograft |
| Classification: | 21 CFR 888.3045 |
| Classification Name: | Resorbable Bone Void Filler |
| Class: | II |
| Product Code: | MOV, MBP |
Legally Marketed Predicate Device
Predicate – Resorbable Mesh Device
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K172130 | MQV, MBP | Resorbable Mesh | |
| Device | IsoTis OrthoBiologics, | ||
| Inc. |
Device Description
The Resorbable Mesh Device is comprised of a resorbable mesh pouch containing demineralized human cortical bone in particulate form. The tissue contained in the pouch is supplied to SeaSpine by a CBER-registered, AATB-accredited tissue bank and is procured, screened, tested and processed in accordance with 21 CFR 1271, Current Good Tissue Practices, AATB Standards for
4
Tissue Banking and other standard procedures. The resorbable mesh pouch is knitted from poly(lactic-co-glycolic) acid (PLGA) fibers which have a high glycolide content.
The Resorbable Mesh Device is offered in various sizes and provided in individually sterile packaged units and ready-to-use. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-9.
Intended Use/Indications for use
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.
Summary of Technological Characteristics
The 115 x 11mm Resorbable Mesh Device is similar to the cited predicate device in regard to components, device description, intended use/indications for use, device characteristics (design, materials, sterility, manufacturing, etc.) and performance.
Summary of Non-Clinical Testing to Support Substantial Equivalence
The subject device is identical to the predicate device in terms of materials, manufacturing process, and intended use. Non-clinical testing was not performed on the subject device, as the subject device does not introduce a new worst case, for the following: biocompatibility, bacterial endotoxin, viral inactivation/clearance, osteoinductive potential and in vivo (animal) safety and performance. A sterilization validation was performed and complies with ISO 11137, Sterilization of Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 10-6.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the Resorbable Mesh Device is substantially equivalent to the cited legally marketed predicate.