(83 days)
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Not Found
No
The summary describes a kit for harvesting and combining bone marrow with osteoconductive material, with no mention of AI or ML technology.
Yes
The device is intended for "treatment of osseous defects", which is a therapeutic purpose.
No
Explanation: The device is intended for harvesting bone marrow and combining it with an osteoconductive material for the treatment of osseous defects. It does not perform any diagnostic function.
No
The device description explicitly states the kit "contains the apparatus required" for harvesting bone marrow, indicating physical components are included, not just software.
Based on the provided information, the Orthos-BMA™ kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to harvest bone marrow and combine it with an osteoconductive material for use in treating osseous defects within the patient's body. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as apparatus for collecting bone marrow and combining it with other materials. This aligns with a surgical tool or kit, not a diagnostic assay or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Orthos-BMA™ kit is used in vivo (within the body) as part of a surgical treatment.
N/A
Intended Use / Indications for Use
The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.
The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique.
The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold.
The Orthos-BMA kit is supplied sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
suitable trained surgical personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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.
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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).
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the word "Orthos" in a bold, sans-serif font, with a stylized graphic to the left of the word. Below "Orthos" is the word "ORTHOBIOLOGICS" in a smaller, sans-serif font. The image is in black and white.
OCT 2 6 2006
KOE2260 510(k) Summary of Safety and Effectiveness
In accordance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the subject device.
| Submitted By: | Orthos Limited |
|---|---|
| Date: | July 2006 |
| Contact Person: | Alan Rorke |
| Managing Director | |
| Proprietary Name: | Orthos-BMA Kit |
| Common Name: | Piston Syringe |
| Classification Name and Reference: | Piston Syringe - 21 CFR 880.5860 |
| Device Product Code: | FMF |
Orthos Limited The Stables, Leigh Court, Abbots Leigh, Bristol, BS8 3RA, UK.
T: +44 (0) 1275 376 377 F: +44 (0) 1275 376 378
DEVICE INFORMATION
A. Device Description
The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique.
The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold.
The Orthos-BMA kit is supplied sterile for single patient use.
B. Intended Use and indications
The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.
The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects, which can occur as a result of trauma, or in skeletal defects created surgically.
C. Substantial Equivalence Rationale
The intended use, the materials and design features employed in the Orthos-BMA™ kit are equivalent to those found in the predicate devices previously cleared for market as described in the pre-market notification. The safety and effectiveness of the Orthos-BMA kit are adequately supported by the data provided within the Pre-market Notification.
Image /page/0/Picture/18 description: The image shows two logos of Lloyd's Register Quality Assurance. The top logo includes the text "ISO9001" at the bottom, while the bottom logo includes the text "ISO13485". Both logos feature a large letter "R" inside a circle, surrounded by the text "LLOYD'S REGISTER QUALITY ASSURANCE".
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected together.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2006
Orthos Limited % Mr. Alan Rorke Managing Director The Sables, Leigh Court Abbots Leights, Bristol BS8 3RA, UK
Re: K062260
Trade/Device Name: The Orthos-BMA™ kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: October 10, 2006 Received: October 13, 2006
Dear Mr. Rorke:
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. Alan Rorke
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson 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) Number (if known): K062260 Device Name: Orthos-BMA™ Kit
Indications for Use:
The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.
The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General. Rostorative, and Neurological De ces
510(a) Number / 60726