(55 days)
Not Found
No
The summary describes a kit of manual tools for bone marrow aspiration and mixing, with no mention of computational or algorithmic components.
No.
The device is used to mix and deliver autologous blood or bone marrow with bone void filler to an orthopedic surgical site, which is a procedural and delivery function, not a direct therapeutic action on a disease or condition.
No
Explanation: The device is used for aspirating bone marrow and blood components, mixing them with bone void filler, and delivering them to an orthopedic surgical site. Its function is to facilitate the preparation and application of materials for treatment, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components (syringes, needle, stylet, adaptor, cleaning rod, mixing bowl, spatula) that constitute the kit.
Based on the provided information, the Aspirex™ - Bone Marrow Aspirate Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of bone marrow, blood, or blood components and their mixing with bone void filler for delivery to an orthopedic surgical site. This is a surgical procedure involving the collection and preparation of biological material for direct use in the body, not for diagnostic testing in vitro (outside the body).
- Device Description: The components are syringes, needles, and mixing tools, all designed for the collection, preparation, and delivery of materials during surgery. There are no components related to analyzing or testing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of any diagnostic function, analysis of samples, or generation of diagnostic results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Aspirex™ kit's function is purely for the collection, preparation, and delivery of materials for a surgical procedure.
N/A
Intended Use / Indications for Use
Aspirex™ – Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon’s choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone void filler and deliver to the orthopedic surgical site.
Product codes
FMF
Device Description
The Aspirex™ - Bone Marrow Aspirate Kit contains two piston syringes: Aspirating Syringe and Infusion Chamber Syringe. These piston syringes along with a single lumen Aspirating Needle, Stylet, Luer-lock Adaptor, Cleaning Rod, Mixing Bowl and Spatula make up the components of the Aspirex™ Kit (will be packaged in various configurations, sizes, and quantities of these components).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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/2 description: The image shows the logo for ISCTIS OrthoBiologics. The logo is black and white. The word "ISCTIS" is in large, bold letters. Below the word "ISCTIS" is the word "OrthoBiologics" in smaller letters.
510(k) Summary for lsoTis OrthoBiologics Aspirex™ - Bone Marrow Aspirate Kit
Sponsor
lsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A
| Contact Person: | Paul Doner |
|---|---|
| Telephone: | (949) 855-7168 |
| Facsimile: | (949) 595-8711 |
Date Prepared: July 2004
Device Name
| Proprietary Name: | Aspirex™ - Bone Marrow Aspirate Kit |
|---|---|
| Common/Usual Name: | Piston Syringe |
| Classification Name: | Piston Syringe (Product Code FMF) |
Predicate Devices
| Proprietary Name: | OrthoVita IMBIBE™ II Syringe (K030208) |
|---|---|
| Wright Medical Bone Graft Syringe (K023088) |
Intended Use
Aspirex™ – Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeo's choice of bone void filler (allograft, autograft or synthetic bone graft material). The rit provides a convenient way to mix autologous blood or bone marrow with bone void filler and deliver to the orthopedic surgical site.
Device Description and Substantial Equivalence Rationale
The Aspirex™ - Bone Marrow Aspirate Kit contains two piston syringes: Aspirating Syringe and Infusion Chamber Syringe. These piston syringes along with a single lumen Aspirating Needle, Stylet, Luer-lock Adaptor, Cleaning Rod, Mixing Bowl and Spatula make up the components of the Aspirex™ Kit (will be packaged in various configurations, sizes, and quantities of these components).
The intended use, materials and design features of the Aspirex™ Kit syringes and components are similar to the predicate devices. Based on the above information, IsoTis OrthoBiologics considers the Aspirex™ - Bone Marrow Aspirate Kit to be substantially equivalent to the OrthoVita IMBIBE II Syringe and the Wright Medical Bone Graft Syringe.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
Mr. Paul Doner Manager, Regulatory Affairs IsoTis OrthoBiologics 2 Goodyear, Suite B Irvine, California 92618
Re: K041991
Trade Name: Aspirex Bone Marrow Aspirate Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 22, 2004 Received: July 23, 2004
Dear Mr. Doner:
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.
2
Page 2 - Mr. Paul Doner
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,
Miriam C. Provost
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
3
510(k) Number (if known):
Device Name: Aspirex™ - Bone Marrow Aspirate Kit
Indications for Use:
Aspirex" - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone void filler and deliver to the orthopedic surgical site.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE ERLOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041991
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