(57 days)
Not Found
No
The device description and intended use describe a standard mechanical syringe for delivering bone graft material. There is no mention of AI or ML in the provided text.
No
The device is a delivery system for bone graft materials, not a device that directly treats a disease or condition itself.
No
The device is described as a piston syringe for the delivery and mixing of bone graft materials, and no mention of diagnosis or diagnostic functions is made in its intended use or description.
No
The device description clearly outlines physical components (syringe barrel, piston, plunger, adapters, tips, cap) and performance studies related to a physical device (ISO 7886-1, biocompatibility testing). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site" and for "facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate". This describes a device used in vivo (within the body) for surgical procedures and material preparation, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a standard syringe for handling and delivering materials, consistent with its intended surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Open Bore Syringe is a surgical delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.
Product codes
FMF
Device Description
The Open Bore Syringe is a standard piston syringe. It consists of a syringe barrel, piston and plunger. The distal end of the barrel is threaded to enable connection to three different adapters while without an attachment, the open end allows for filling of the bone graft material. Three distinct tips enable connection to a standard female Luer or dispensing through a tapered nozzle or extended tapered nozzle, and can be used depending on the viscosity of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel from, or facilitate collection into the barrel.
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
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)
The Open Bore Syringe is tested to conform to the recognized standard, ISO 7886-1 where applicable. Biocompatibility testing of the Open Bore Syringe has been performed to confirm that the device is safe.
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
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
K04/34-4
JUL 1 6 2004
510(k) Summary for IsoTis OrthoBiologics Open Bore Syringe
1. SPONSOR
IsoTis NV Prof. Bronkhorstlaan 10 3723 MB Bilthoven The Netherlands
IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A
| Contact Person: | E. Schutte |
|---|---|
| Telephone: | +31-(0) 30-2295125 |
| Facsimile: | +31-(0) 30-2280255 |
Date Prepared: May 2004
2. DEVICE NAME
| Proprietary Name: | Open Bore Syringe |
|---|---|
| Common/Usual Name: | Piston Syringe |
| Classification Name: | Piston Syringe (Product Code FMF) |
3. PREDICATE DEVICES
| Proprietary Name: | OrthoVita Imbibe™ Bone Marrow Aspiration Syringe |
|---|---|
| Interpore Inducer Bone Graft Delivery Syringe | |
| Common/Usual Name: | Piston Syringe |
| Classification Name: | Piston Syringe (Product Code FMF) |
1
4. DEVICE DESCRIPTION
The Open Bore Syringe is a standard piston syringe. It consists of a syringe barrel, piston and plunger. The distal end of the barrel is threaded to enable connection to three different adapters while without an attachment, the open end allows for filling of the bone graft material. Three distinct tips enable connection to a standard female Luer or dispensing through a tapered nozzle or extended tapered nozzle, and can be used depending on the viscosity of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel from, or facilitate collection into the barrel.
INTENDED USE ડ.
The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Open Bore Syringe and the predicate devices are all similar in design, materials of construction and function as a piston syringe. All of the devices are provided sterile and non-pyrogenic for single patient use. The only difference between the proposed device and the predicate devices is in regard to the specific design configurations. The minor differences in design do not affect safety or effectiveness since all the devices carry out the same function. The safety and biocompatibility testing performed for and the long history of safe clinical use of piston syringes for delivery of bone grafts support the safe use of the Open Bore Syringe. The Open Bore Syringe also meets the requirements of ISO 7886-1 where applicable.
7. TESTING
The Open Bore Syringe is tested to conform to the recognized standard, ISO 7886-1 where applicable. Biocompatibility testing of the Open Bore Syringe has been performed to confirm that the device is safe. The devices to which the Open Bore Syringe claims substantial equivalence are the Orthovita Imbibe Bone Marrow Aspiration Syringe (K011087) and the Interpore Inducer Bone Graft Delivery Syringe (K972842) have been used safely for many years in the clinical environment.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Public Health Service
JUL 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IsoTis NV c/o John F. Kay, Ph.D. Chief Scientific Officer IsoTis OrthoBiologics 2 Goodyear Irvine, California 92618
Re: K041344
Trade/Device Name: Open Bore Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 18, 2004 Received: May 25, 2004
Dear Dr. Kay:
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 - John F. Kay, Ph.D.
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,
Mark A. Millan
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) Number (if known): _ K041344
Device Name: Open Bore Syringe
Indications for Use:
The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY J
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mikkelson
Division Sign-Division of General, Restorative, and Neurological Devices