(361 days)
Not Found
No
The summary describes a physical bone graft material and its properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implant intended to fill bony voids or gaps and is replaced with bone during healing, indicating a direct therapeutic effect on the skeletal system.
No
The device is an implantable bone graft material intended to fill bony voids or gaps, not to diagnose a condition.
No
The device description clearly states it is a "composite of synthetic hydroxyapatite and lactide-caprolactone copolymer" and a "shapable, absorbable, osteoconductive putty bone graft," indicating it is a physical 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 bony voids or gaps in the skeletal system (pelvis and extremities). This is a therapeutic/surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is a bone graft material intended for implantation. This is a medical device used for treatment, not for diagnosing a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly described as an implantable bone graft material used in surgical procedures.
N/A
Intended Use / Indications for Use
GaiaBoneTM Bioabsorbable Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system. i.e., the pelvis and extremities. These osseous defects may be surgically created of traumatic injury to the bone and are not intrinsic to the stability of the boneTM Bioabsorbable Bone Graft resorbs and is replaced with bone during the healing process.
Product codes
MOV
Device Description
GaiaBone™ Bioabsorbable Bone Graft is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and lactide-caprolactone copolymer. The composite material is a shapable, absorbable, osteoconductive putty bone graft. It is available in cylinders. This bone graft material contains approximately 50% mineral by weight. GaiaBone™ Bioabsorbable Bone Graft is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).
GaiaBone™ is easy to be shaped and designed to retain its shape and physical integrity following implantation into a bony site. The product is sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis and extremities
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 performed on the subject device includes tests for: anticollapse property, In vitro degradation, sterilization, product shelf-life and bone defect model in rabbit. The anti-collapse and degradation property was verified according to clinical requirements. According to the test results, GaiaBone™ Bioabsorbable Bone Graft shows comparable performance with the predicate device. Assessment of biocompatibility of GaiaBone™ Bioabsorbable Bone Graft was performed according to ISO 10993-1:2018, demonstrating acceptable biological safetv profiles. Sterilization complies with ISO 11137, Sterilization of Health Care Products - Radiation to ensure a sterility assurance level (SAL) of 106. Product shelf-life testing was evaluated to ensure the labeled shelf life. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method. The LAL testing met the limit acceptance criterion of ≤ ≥ 20 EU/device, based upon the recommendations for implanted devices in the FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 21, 2016 (Section V, A, 4). Results of a rabbit femoral critical defect study demonstrated that after 12 weeks, there was a difference of 5.8% in new bone formation with the GaiaBone™ Bioabsorbable Bone Graft as compared to the empty defect group. The autograft control group demonstrated a difference of 14.5% in new bone formation as compared to the empty defect group. Clinical performance has not been evaluated.
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.
0
February 3, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. To the right of the blue square is the full name of the agency, "U.S. FOOD & DRUG ADMINISTRATION", in blue letters.
Corliber (Shenzhen) Medical Device Co., Ltd. % Li-Ting Lu Regulatory Affair Cosmos Biomed Consulting CO., Ltd Room 1201, No.1, 188 Alley, Shuangliu Road Changning District, Shanghai City, China
Re: K220337
Trade/Device Name: GaiaBone™ Bioabsorbable Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 3, 2023 Received: January 3, 2023
Dear Li-Ting Lu:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Laurence D. Coyne -S
Laurence D. Coyne, Ph.D. 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) K220337
Device Name GaiaBoneTM Bioabsorbable Bone Graft
Indications for Use (Describe)
GaiaBoneTM Bioabsorbable Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system. i.e., the pelvis and extremities. These osseous defects may be surgically created of traumatic injury to the bone and are not intrinsic to the stability of the boneTM Bioabsorbable Bone Graft resorbs and is replaced with bone during the healing process.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Corliber (Shenzhen) Medical Device Co., Ltd. GaiaBone™ Bioabsorbable Bone Graft Traditional 510(k)
K220337 Page 1 of 3
510(k) SUMMARY
1. Contact Person
Name: Sun Yang Title: General Manager E-mail: sunyang@corliber.com Office address: #103, BLK 6, 14 Zhongxing Rd, Kengzi Sub-district, Pingshan District, Shenzhen City, Guangdong Province, China. Tel: (O) +86-755-23007976
2. Device Name and Classification
| Product Name: | GaiaBone™ Bioabsorbable Bone Graft |
|---|---|
| Classification Name: | Filler, Bone Void, Calcium Compound |
| Common or Usual Name: | Resorbable calcium salt bone void filler device |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR 888.3045 |
| Device Class: | Class II |
| Product Code: | MQV |
3. Predicate Device(s)
| Product Name: | BongoldTM Bone Graft Material (K141725) |
|---|---|
| Classification Name: | Filler, Bone Void, Calcium Compound |
| Common or Usual Name: | Resorbable calcium salt bone void filler device |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR 888.3045 |
| Device Class: | Class II |
| Product Code: | MQV |
4. Device Description
GaiaBone™ Bioabsorbable Bone Graft is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and lactide-caprolactone copolymer. The composite material is a shapable, absorbable, osteoconductive putty bone graft. It is available in cylinders. This bone graft material contains approximately 50% mineral
4
by weight. GaiaBone™ Bioabsorbable Bone Graft is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).
GaiaBone™ is easy to be shaped and designed to retain its shape and physical integrity following implantation into a bony site. The product is sterile and for single use only.
5. Intended Use / Indications for Use
GaiaBone™ Bioabsorbable Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GaiaBone™ Bioabsorbable Bone Graft resorbs and is replaced with bone during the healing process.
6. Summary of Technological Characteristics
GaiaBone™ Bioabsorbable Bone Graft is a shapable, absorbable, osteoconductive and anti-collapse bone graft in putty form. The product is composed of matrix of hydroxyapatite per ASTM F1185 and lactide-caprolactone copolymer per ASTM F2579.
GaiaBone™ Bioabsorbable Bone Graft provide the same intended use as predicate device with similar composition concept, hydroxyapatite and degradable polymer. GaiaBone™ Bioabsorbable Bone Graft is available in three volumes, with the "putty" characteristic derived from its polymer composition, it can be manipulated to fit the bone void like the predicate device according to the instructions provided by IFU.
7. Summary of Non-Clinical Testing to Support Substantial Equivalence
Non-clinical testing performed on the subject device includes tests for: anticollapse property, In vitro degradation, sterilization, product shelf-life and bone defect model in rabbit.
The anti-collapse and degradation property was verified according to clinical requirements. According to the test results, GaiaBone™ Bioabsorbable Bone Graft shows comparable performance with the predicate device.
Assessment of biocompatibility of GaiaBone™ Bioabsorbable Bone Graft was performed according to ISO 10993-1:2018, demonstrating acceptable biological safetv profiles.
Sterilization complies with ISO 11137, Sterilization of Health Care Products -
5
Radiation to ensure a sterility assurance level (SAL) of 106. Product shelf-life testing was evaluated to ensure the labeled shelf life.
Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method. The LAL testing met the limit acceptance criterion of ≤ ≥ 20 EU/device, based upon the recommendations for implanted devices in the FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 21, 2016 (Section V, A, 4).
Results of a rabbit femoral critical defect study demonstrated that after 12 weeks, there was a difference of 5.8% in new bone formation with the GaiaBone™ Bioabsorbable Bone Graft as compared to the empty defect group. The autograft control group demonstrated a difference of 14.5% in new bone formation as compared to the empty defect group. Clinical performance has not been evaluated.
8. Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
9. Conclusion
GaiaBone™ Bioabsorbable Bone Graft has the same intended use, similar technological characteristics, and principles of operation as the predicate device. The results of the in vitro performance characterization, biocompatibility studies, and animal performance study show that the GaiaBone™ Bioabsorbable Bone Graft is as safe as the predicate device and substantially equivalent to the predicate device.