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.

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.

AI/ML Overview

This 510(k) summary is for the IsoTis OrthoBiologics Open Bore Syringe. Due to its nature as a medical device (a piston syringe), the "study" described focuses on equivalence to predicate devices and adherence to recognized standards, rather than a clinical trial with human subjects and specific AI performance metrics. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided information, addressing the relevant points:

Device: IsoTis OrthoBiologics Open Bore Syringe
Device Type: Medical Device (Piston Syringe)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device was tested against)	Reported Device Performance (How the device met the criteria)
Compliance with ISO 7886-1 (where applicable)	The Open Bore Syringe is tested to conform to the recognized standard, ISO 7886-1 where applicable.
Biocompatibility	Biocompatibility testing of the Open Bore Syringe has been performed to confirm that the device is safe.
Substantial Equivalence to Predicate Devices	The Open Bore Syringe and the predicate devices (OrthoVita Imbibe™ Bone Marrow Aspiration Syringe and Interpore Inducer Bone Graft Delivery Syringe) are all similar in design, materials of construction, and function as a piston syringe. The minor differences in design do not affect safety or effectiveness.
Sterility (implied for single patient use)	All of the devices are provided sterile.
Non-pyrogenic (implied for single patient use)	All of the devices are provided non-pyrogenic.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. For physical device testing against standards like ISO 7886-1, the sample size would typically be determined by the standard itself or internal quality control procedures, but it's not reported in this summary.
Data Provenance: Not applicable in the context of clinical data. The data refers to engineering and biocompatibility testing results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. For this type of medical device (a piston syringe), "ground truth" as it relates to clinical diagnosis or AI output is not relevant. The performance evaluation is based on objective measurements against engineering standards and material properties, overseen by internal quality control and regulatory review, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or in complex diagnostic scenarios, which do not apply to the physical testing of a syringe.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed to assess the effectiveness of an AI system, often in comparison to human readers. This device is a manual piston syringe and does not involve AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is purely mechanical and has no algorithm or AI component.

7. The Type of Ground Truth Used

Engineering Standards and Material Specifications: The "ground truth" for this device's performance is established by recognized international standards (ISO 7886-1), biocompatibility requirements, and the functional characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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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)

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4. DEVICE DESCRIPTION

INTENDED USE ડ.

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.

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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:

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

Regulation Number and Section

§ 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).