(308 days)
OsteoLaso Granule & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoLaso Granule & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granule & Strips are intended to be pasked into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremeties, posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
This document describes the 510(k) summary for the OsteoLaso Granule & Strips device, a bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device, Kasios TCP (K042340). As such, it does not detail acceptance criteria or a study proving the device meets those criteria in the way a performance study for a diagnostic or AI device would.
Instead, the "acceptance criteria" here are essentially the characteristics and properties of the predicate device, which the OsteoLaso device aims to match or exceed to demonstrate equivalence. The "study" is the set of tests performed to compare these characteristics between OsteoLaso and the predicate.
Here's the information extracted and formatted, keeping in mind the nature of this 510(k) submission:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Predicate Device (Kasios TCP - K042340) Acceptance Criteria | OsteoLaso Granule & Strips Reported Performance | Equivalence Claim |
|---|---|---|---|
| Biocompatibility | ISO 10993:2003 standards | Meets ISO 10993:2003 standards | Equivalent |
| Chemical Composition | 99.9% Beta-Trichalcium Phosphate (ASTM F1088-87) | 99.99% Beta-TriCalcium Phosphate (ASTM F1088-87) | Equivalent |
| Pore Size | 200-500um | 200-500um | Equivalent |
| Percentage of Porosity | 60-80% | Greater than 75% | Equivalent |
| Indications for Use | Bone void filler | Bone void filler | Equivalent |
| Component Characteristics | Packed with a container | Packed with a container | Equivalent |
| Pore Interconnectedness | Not explicitly quantified, but claimed equivalent | Not explicitly quantified, but claimed equivalent | Equivalent |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes in terms of a "test set" for clinical data. The tests described are material property tests (biocompatibility, chemical composition, pore size, porosity). The data provenance is related to these material tests, which would be performed in a laboratory setting. There is no mention of country of origin of data, nor whether it is retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns material properties and equivalence to a predicate device, not the interpretation of complex data by human experts to establish "ground truth" for a test set in the way a diagnostic AI would require.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as would be used for human expert interpretation of clinical data.
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 device is a bone void filler, not an AI or diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For this type of device, the "ground truth" is established through standardized material testing and established medical knowledge regarding bone void fillers and predicate devices.
- Biocompatibility: Conformance to ISO 10993:2003 standards.
- Chemical Composition: Conformance to ASTM F1088-87.
- Physical Properties (Pore Size, Porosity): Quantitative measurements compared against the predicate's known characteristics.
- Indications for Use: Comparison of intended uses based on established medical practice and the predicate's existing clearance.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
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PAGE 9 OF 2
FEB 1 4 2012
510(k) Summary for K111018
- Company Making the Submission 1.
| Submitter | |
|---|---|
| Name | AtPac Medical |
| Address | 848 N Rainbow Blvd #3284Las Vegas, NV 89107 |
| Phone | 503.970.4601 |
| Fax | 805.669.4221 |
| Contact | Scott Howard |
| scott@atpacmedical.com |
-
- Device
| Trade Name: | OsteoLaso |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name: | Resorbable Calcium Salt Bone Void Filler |
3. Predicate Device: Kasios TCP (K042340)
Biocompatability was tested by using ISO 10993:2003 standards. Results showed equivalence to predicate device of Kasios TCP (K042340). Chemical composition was tested using ASTM International standards section ASTM F1088-87, which is the International Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Results showed 99.99% Beta-TriCalcium Phosphate in equivalence to predicate device of Kasios TCP (K042340) at 99.9%Beta-TriCalcium Phosphate. Pore size was tested. Results showed 200-500um equivalence to predicate device of Kasios TCP (K042340). Percentage of Porosity was tested. Results showed greater than 75% which is equivalent to predicate device of Kasios TCP (K042340) at 60-80%. Finally, OsteoLaso and Kasios TCP are both Indicated for Use as a Bone Void Filler.
4. Description
OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
న. Indication for Use
OsteoLaso Granule & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoLaso Granule & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granule & Strips are intended to be pasked into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremeties, posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
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6. Review
OsteoLaso Granule & Strips has equivalent technological characteristics to the predicate device in the following ways: Biocompatability, Pore Size, Pore Interconnectedness, Indications for Use. Chemical Properties.
Component Equivalence OsteoLaso and the predicate are both packed with a container.
Indications for Use Equivalence OsteoLaso and the predicate are both indicated as a bone void filler.
7. Conclusion
Based on the information provided in this premarket notification AtPac Medical LLC concludes that OsteoLaso Granule & Strips is safe and effective and substantially equivalent to predicate device as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AtPac Medical, LLC % Mr. Scott Howard CEO 848 North Rainbow Boulevard, Suite 3284 Las Vegas. Nevada 89107
FEB 1 4 2012
Re: K111018
Trade/Device Name: OsteoLaso Granule and Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: February 6, 2012 Received: February 6, 2012
Dear Mr. Howard:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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. Scott Howard
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you desire specific advisor in the senters Offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Submission
Indication for Use
510(k) Number (if known) K111018
Device Name:
OsteoLaso Granules & Strips
.
Indication for Use:
OsteoLaso Granules & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the boney structure. OsteoLaso Granules & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granules & Strips are intended to be packed into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremities posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Prescription Use X AND/OR Over-The-Counter Use (21CRF 801 Subpart D) (21CRF 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K111018
§ 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.