(88 days)
Not Found
No
The device description focuses on the biological and material composition of a bone graft putty and its hydration process. There is no mention of any computational or algorithmic components, let alone AI or ML. The performance studies are biological/material in nature.
Yes
The device, "Dry DBM-A Putty," is intended to fill voids and gaps in the skeletal system and is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis to facilitate bone repair and regeneration. This falls under the definition of a therapeutic device as it treats or alleviates a medical condition (skeletal defects and gaps) and promotes healing.
No
This device is a bone graft material intended to fill voids and gaps in the skeletal system, not to diagnose a condition.
No
The device description clearly states it is a physical product made of demineralized human bone and other materials, provided in a syringe. It is a bone graft material, 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 to fill voids and gaps in the skeletal system and act as a bone graft extender. This is a therapeutic and structural function within the body.
- Device Description: The device is a bone graft material made from demineralized human bone and other components, intended for surgical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a disease or condition. The hydration with saline, blood, or BMA is for preparing the material for implantation, not for diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dry DBM-A Putty 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
Product codes
MQV, MBP
Device Description
Dry DBM-A Putty is made with demineralized human bone mixed with poloxamer resorbable reverse phase medium. Demineralized human bone is in the form of demineralized bone matrix (DBM) and a dispersed form of DBM, referred to as Accell Bone Matrix (ABM). Cancellous bone chips may also be added. Dry DBM-A Putty is formulated into a freeze-dried putty form and is provided in a sterile, single use package. As a human-derived material, some variations in the product should be expected, such as appearance and handling. Dry DBM-A Putty is packaged in a standard syringe.
The device is hydrated at the point of use with saline, blood, or bone marrow aspirate (BMA) (hydration fluid). Utilizing a standard male luer syringe available to the clinician in the Operating Room (not provided with the finished device), it is recommended to hydrate at a 0.8:1 fluid volume (relative to the stated graft volume). The hydration fluid is dispensed from the male luer syringe into the device syringe until reconstitution of the dry putty is achieved.
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
clinician in the Operating Room
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 testing performed on the subject device includes tests for: bacterial endotoxin, in vivo (animal) safety and performance, sterilization, viral inactivation/clearance, osteoinductive potential, and product shelf-life. As the subject and predicate devices utilize equivalent raw materials, manufacturing processes, packaging, and sterilization, the subject device does not introduce a new worst case for biocompatibility. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing and USP Bacterial Endotoxin Test and has been validated ensure a BET limit of ≤20 EU/Device. An in vivo (animal) study for safety and performance demonstrated comparable resorption, remodeling and rates of fusion when compared to an autograft control. The study employed various analyses and endpoints were assessed at several time points. Sterilization complies with ISO 11137, Sterilization of Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 105. The viral clearance study concluded significant viral inactivation/clearance potential for a wide range of potential viruses. Product shelf-life testing was evaluated to ensure that the subject device maintains osteoinductive potential, acceptable hydration, and sterility over the labeled shelf life.
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
§ 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.
0
October 4, 2021
Image /page/0/Picture/1 description: The image contains the logo for 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SeaSpine Corporation Caryn Sailor Associate Manager, Regulatory Affairs 2 Goodyear Irvine, California 92618
Re: K212135
Trade/Device Name: Dry DBM-A Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, MBP Dated: July 9, 2021 Received: July 12, 2021
Dear Caryn 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.
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
1
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 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,
Laura C. Rose, Ph.D. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Dry DBM-A Putty
Indications for Use (Describe)
Dry DBM-A Putty 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
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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510(k) Number: K212135 Dated: September 24, 2021
Affairs
| 510(k) Summary | K212135 | |
|---|---|---|
| Contact Details | ||
| Owner Operator Name: | ||
| Address: | SeaSpine Orthopedics Corporation | |
| 5770 Armada Drive, Carlsbad CA | ||
| Establishment Name: | ||
| Address: | IsoTis OrthoBiologics, Inc. | |
| 2 Goodyear, Irvine, CA | ||
| Contact person: | ||
| Email address: | ||
| Phone number: | ||
| Fax number: | Caryn Sailor, Associate Manager, Regulatory | |
| caryn.sailor@seaspine.com | ||
| (949) 855-7174 | ||
| (949) 595-8711 | ||
| Date Prepared: | September 24, 2021 | |
| Device Name | ||
| Device/Trade Name: | Dry DBM-A Putty | |
| Common Name: | Demineralized Bone Matrix Allograft | |
| Classification: | 21 CFR 888.3045 | |
| Classification Name: | Resorbable Bone Void Filler | |
| Class: | II | |
| Product Code: | MQV, MBP |
Legally Marketed Predicate Device
Predicate – Accell Evo3c
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K091193 | MQV, MBP | Accell Evo3c | IsoTis OrthoBiologics, Inc.* |
*IsoTis OrthoBiologics, Inc. is a subsidiary of SeaSpine Orthopedics Corporation. The subject and predicate devices are both manufactured by IsoTis.
Device Description
Dry DBM-A Putty is made with demineralized human bone mixed with poloxamer resorbable reverse phase medium. Demineralized human bone is in the form of demineralized bone matrix
4
(DBM) and a dispersed form of DBM, referred to as Accell Bone Matrix (ABM). Cancellous bone chips may also be added. Dry DBM-A Putty is formulated into a freeze-dried putty form and is provided in a sterile, single use package. As a human-derived material, some variations in the product should be expected, such as appearance and handling. Dry DBM-A Putty is packaged in a standard syringe.
The device is hydrated at the point of use with saline, blood, or bone marrow aspirate (BMA) (hydration fluid). Utilizing a standard male luer syringe available to the clinician in the Operating Room (not provided with the finished device), it is recommended to hydrate at a 0.8:1 fluid volume (relative to the stated graft volume). The hydration fluid is dispensed from the male luer syringe into the device syringe until reconstitution of the dry putty is achieved.
Intended Use/Indications for Use
Dry DBM-A Putty 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.
Summary of Technological Characteristics
The subject 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
Non-clinical testing performed on the subject device includes tests for: bacterial endotoxin, in vivo (animal) safety and performance, sterilization, viral inactivation/clearance, osteoinductive potential, and product shelf-life. As the subject and predicate devices utilize equivalent raw materials, manufacturing processes, packaging, and sterilization, the subject device does not introduce a new worst case for biocompatibility. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing and USP Bacterial Endotoxin Test and has been validated ensure a BET limit of ≤20 EU/Device. An in vivo (animal) study for safety and performance demonstrated comparable resorption, remodeling and rates of fusion when compared to an autograft control. The study employed various analyses and endpoints were assessed at several time points. Sterilization complies with ISO 11137, Sterilization of Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 105. The viral clearance study concluded significant viral inactivation/clearance potential for a wide range of potential viruses. Product shelf-life testing was evaluated to ensure that the subject device maintains osteoinductive potential, acceptable hydration, and sterility over the labeled shelf life.
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 subject device is substantially equivalent to the cited legally marketed predicate.