(88 days)
Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
The provided text describes the 510(k) summary for the Callos™ Bone Void Filler. This submission is for a medical device and not an AI/ML powered device, so many of the requested fields related to AI/ML specific studies (e.g., test set, ground truth methods, MRMC studies, training set details) are not applicable or extractable from this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and animal testing.
Here's the information that can be extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Properties: Density, Porosity, Dimensional Stability, Injectability, Setting Time, Working Time, pH, Setting Temperature | Non-clinical testing included evaluation of these properties. (Specific values are not provided in this summary, but the conclusion is that the device is "as safe and effective as the predicate device," implying these properties met an acceptable standard or were equivalent to the predicate). |
| Biocompatibility: Non-cytotoxic, Non-systemic toxic, Non-mutagenic, Non-irritative, Non-pyrogenic, Non-sensitizing | Biocompatibility testing demonstrated that the material meets all these criteria. |
| Solubility and Dissolution Rate | Comparative testing with the predicate device showed equivalence. |
| X-Ray Diffraction (XRD) | Comparative testing with the predicate device showed equivalence. |
| Fourier Transform Infrared (FTIR) Spectroscopy | Comparative testing with the predicate device showed equivalence. |
| Elemental Analysis | Comparative testing with the predicate device showed equivalence. |
| In vivo Performance (Histological, Chemical, Crystallographical, and Mechanical Analyses following implantation) | Animal testing demonstrated substantial equivalence to the predicate device. This included histological, chemical, crystallographical, and mechanical analyses, implying favorable or equivalent outcomes to the predicate in these aspects of tissue integration and material behavior within a living system. (Specific metrics or thresholds for "favorable" or "equivalent" are not detailed in this summary). |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria is a series of non-clinical and animal tests, along with comparative testing against a predicate device. The primary goal was to demonstrate "substantial equivalence" to the legally marketed predicate device, Norian SRS Bone Void Filler (K011897).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable as this is a materials science and animal study, not an AI/ML study with a distinct "test set" of data samples in the same sense. The "test set" would encompass the various samples of the Callos Bone Void Filler material used for the non-clinical tests and the animals used in the in-vivo study. The exact number of material samples or animals is not specified in this summary.
- Data Provenance: Not explicitly stated, but the studies would have been conducted in a laboratory or animal testing facility context. The data is prospective as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth for material properties, chemical analyses, and biocompatibility is established through standardized laboratory testing methods rather than expert consensus on diagnostic images. For the animal study, "ground truth" would be derived from the histological, chemical, crystallographical, and mechanical analyses performed by qualified scientists/pathologists, but the number and specific qualifications of these individuals are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies involving human readers and are not relevant for material science or animal studies of this nature.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device submission for a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance was established through:
- Quantitative measurements from non-clinical laboratory tests (e.g., density, pH, setting time).
- Standardized analytical techniques (e.g., XRD, FTIR, elemental analysis) confirming material composition and structure.
- Biocompatibility assays conforming to recognized standards (e.g., for cytotoxicity, irritation).
- Histological, chemical, crystallographical, and mechanical analyses of animal tissues and implants to assess in-vivo resorption, bone ingrowth, and material behavior.
8. The sample size for the training set:
Not applicable. This is not an AI/ML powered device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set.
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K0305541
MAY 2 0 2003
510(k) Summary
| Sponsor: | Skeletal Kinetics, LLC10201 Bubb Road, Cupertino, CA 95014 |
|---|---|
| Contact Person: | Duran Yetkinler, M.D., Ph.D. |
| Phone Number: | 408 366 5002 |
| Fax Number: | 408 366 1077 |
| Prepared: | February 18, 2003 |
Trade Name: Callos™M Bone Graft Substitute Common Name: Classification: Unclassified Product Code: 87 MVQ
Predicate Device: Callos Bone Void Filler is substantially equivalent to Norian SRS Bone Void Filler (K011897).
Device Description: Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
Intended Use/Indications for Use: Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Technological Characteristics: Similar to the predicate device. Callos Bone Void Filler is an injectable, moldable, biocompatible, resorbable calcium phosphate based material intended for identical indications.
Performance Data: Non-clinical testing included material properties such as density, porosity, dimensional stability, injectability, setting time, working time, pH, and setting temperature. Biocompatibility testing demonstrated that the material is non-cytotoxic, non-systemic toxic, non-mutagenic, non-irritative, non-pyrogenic, and non-sensitizing. Comparative testing with the predicate device showed equivalence in terms of solubility and dissolution rate, X-Ray Diffraction (XRD), Fourier Transform Infrared (FTIR) spectroscopy and elemental analysis. Animal testing demonstrated substantial equivalence to the predicate device following in vivo implantation. Histological, chemical, crystallographical, and mechanical analyses showed substantial equivalence.
Basis for Substantial Equivalence: The Callos Bone Void Filler has the same intended use, identical indications, and very similar technological characteristics as the predicate device. Any minor technological differences between Callos Bone Void Filler and its predicate device do not raise any new issues of safety or effectiveness.
Skeletal Kinetics, LLC - Confidential
page 1 of 2 Appendix C
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Functional, biocompatibility, and animal testing results show that the Callos Bone Void Filler is as safe and effective as the predicate device. Thus, the Callos Bone Void Filler is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Skeletal Kinetics, LLC c/o Mr. Howard Holstein Regulatory Counsel Hogan & Hartson, LLC 555 13th Street, N.W. Washington, DC 20004
Re: K030554
Trade/Device Name: Callos™ Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: February 20, 2003 Received: February 21, 2003
Dear Mr. Holstein:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Howard Holstein
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Indications for Use
510(k) Number (if known):
Device Name:
Callos Bone Void Filler
403055
Page
of
Indications for use:
Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of General, Restorative and
Neurological Devices
510(k) Number K030554
§ 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.