(308 days)
Not Found
No
The summary describes a bone void filler material and its physical and chemical properties, with no mention of AI or ML.
No
The device is a bone void filler that resorbs and is replaced by bone during the healing process, acting as a structural support rather than directly performing a therapeutic function.
No
This device is a bone void filler intended for use in surgical repair of osseous defects, not for diagnosing medical conditions.
No
The device description clearly states that the device "consists of beta-tricalcium phosphate, and polyphosphate" and is a "bone graft substitute," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- OsteoLaso Granule & Strips Function: The description clearly states that OsteoLaso Granule & Strips are intended for use within the body as a bone void filler. It is implanted into bone defects to aid in the healing process.
The intended use and device description are consistent with a surgically implanted medical device, not an in vitro diagnostic test.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremeties, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Chemical composition: 99.99% Beta-TriCalcium Phosphate.
Pore size: 200-500um.
Percentage of Porosity: greater than 75%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for ATPAC MEDICAL. The logo is in black and white and features the letters "ATPAC" in a bold, sans-serif font. The word "MEDICAL" is written in a smaller font size below the letters "ATPAC". The logo is simple and professional.
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 #3284 |
| Las 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.
1
Image /page/1/Picture/0 description: The image shows the logo for ATPAC MEDICAL. The logo is in black and white and features the letters "A", "T", "P", "A", and "C" in a stylized font. Below the letters "ATPAC" is the word "MEDICAL" in a smaller font. The logo is simple and professional.
Image /page/1/Picture/1 description: The image contains handwritten text on a white background. The text "KIII018" is on the first line, and the text "PAGE 2 OF 2" is on the second line. The text is written in black ink and appears to be part of a document.
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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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
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.
«.
3
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
4
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