The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Device Description

The IMBIBE II Syringe consists of a calibrated hollow barrel and a moveable piston. At the distal end of the syringe, there is a Luer-lock nozzle for fitting the connector (hub) of a single lumen aspiration needle. A Luer-lock nozzle makes a stable connection between the syringe and needle. A threaded screw cap (containing the Luer-lock nozzle) at the distal end of the syringe can be removed to allow the user to fill the syringe with his or her choice of bone void filler. The proximal end of the syringe contains a moveable piston. A Luerlock nozzle is located in the center of the piston. This connector provides a mechanism for either of two actions.

Fitting the male connector of a vacuum application device, such as a secondary empty I piston syringe.
. Fitting the male connector of a secondary pre-filled piston syringe containing bone marrow, autologous blood, plasma or other blood components.
Prior to use, the IMBIBE II syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). Two methods can be used to imbibe the bone void filler with bone marrow or autologous blood. Method I collects blood or marrow by way of a needle attached to the distal Luer-lock and vacuum/aspiration applied by way of a secondary syringe attached to the proximal Luer-lock. Method II fills the IMBIBE II Syringe through the proximal port (Luer-lock) with blood or marrow collected by way of a secondary syringe.
Once the desired volume of blood or marrow has been collected and mixed with the bone void filler, the secondary syringe and/or aspiration needle are removed. A pushrod is attached to the piston at the proximal end of the IMBIBE II Syringe by way of the female Luer-lock, the distal cap is unscrewed and the contents of the syringe are delivered to the surgical site by extruding the mixed bone void filler.

AI/ML Overview

This document, K030208, is a 510(k) premarket notification for the IMBIBE II Syringe. The information provided focuses on the device description, intended use, and comparison to a predicate device for demonstrating substantial equivalence. It does not contain a study that establishes performance through predefined acceptance criteria. Instead, it relies on demonstrating that the new device is substantially equivalent to an already legally marketed predicate device (IMBIBE Bone Marrow Aspiration Syringe, K011087) by comparing their characteristics and intended use.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment are not applicable or cannot be extracted from this specific document.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal "acceptance criteria" in the context of a performance study with reported metrics for the IMBIBE II Syringe. Instead, it compares the characteristics of the IMBIBE II Syringe with those of the predicate device (IMBIBE Bone Marrow Aspiration Syringe). The underlying implicit "acceptance criterion" for this 510(k) submission is that the IMBIBE II Syringe is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

The comparison table provided in the document for substantiating equivalence is:

Feature	IMBIBE II Syringe	Predicate: IMBIBE Bone Marrow Aspiration Syringe NML1087
Syringe Type	Piston Syringe	Piston Syringe
Intended Use	To collect blood components/bone marrow for mixing with bone graft and subsequent delivery to the surgical site.	To collect blood components/bone marrow for mixing with bone graft and subsequent delivery to the surgical site.
Principle of Operation	Syringe used to collect blood, marrow. Removable cap allows syringe to be filled with graft material. Syringe provides for mixing of blood, marrow with graft material. Removable screw cap allows for delivery of blood, marrow filled graft to surgical site. Luer-lock (nozzle) at the proximal end of the barrel allows connection of a secondary piston syringe.	Syringe used to collect blood, marrow. Removable cap allows syringe to be filled with graft material. Syringe provides for mixing of blood, marrow with graft material. Removable screw cap allows for delivery of blood, marrow filled graft to surgical site.
Overall Length	3.5, 4.6, 3.9, 5.3 inches (for 5cc, 10cc, 15cc, 30cc volumes)	2.9 inches (for 10cc volume)
Barrel Diameter	0.73, 0.73, 1.05, 1.05 inches, OD (for 5cc, 10cc, 15cc, 30cc volumes)	0.73 inches, OD (for 10cc volume)
Tip Type	Gasket	Gasket
Volume	5, 10, 15, 30 cc	10 cc
Nozzle Type	Luer-lock	Luer-lock
Barrel Markings	Graduated scale	Graduated scale
Lubricant Composition	None	Silicone
Lubricant amt/cm²	Not Applicable	100mg ± 5mg
Barrel Transparency	Transparent, no radiopacifiers	Transparent, no radiopacifiers
Reuse	Single use only	Single use only
Biocompatibility	Established by way of legally marketed device, IMBIBE Bone Marrow Aspiration Syringe, K011087 and ISO 10993 testing of adhesive	Established
Materials	Polycarbonate, ABS, Silicone, Dymax UV adhesive 1187-M-T	Polycarbonate, ABS, Silicone
Labeling	See Exhibit B. Same as predicate except additional information regarding directions for use.	See Exhibit C
Sterility	Sterilized by gamma radiation	Sterilized by gamma radiation

The reported performance is essentially the listed characteristics of the IMBIBE II Syringe, which are deemed substantially equivalent to the predicate. The major difference highlighted is the additional proximal Luer-lock on the IMBIBE II Syringe and the wider range of available volumes. The lack of lubricant is also noted. Biocompatibility for the new device is established by reference to the predicate and ISO 10993 testing for the adhesive.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a medical device for aspirations/delivery, not an AI or diagnostic device that would typically involve a "test set" or "data provenance" in the way these terms are usually applied to machine learning models or clinical diagnostic studies. This is a 510(k) premarket notification for a physical medical device. No clinical "test set" in this context is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document is for a physical medical device, not a diagnostic or AI algorithm requiring expert ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document is for a physical medical device, not a diagnostic study requiring adjudication for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a physical medical device, not an AI-assisted diagnostic device that would involve MRMC studies or human reader improvement with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of a diagnostic or AI study. The "ground truth" for this submission is based on the known, established safe and effective performance of the predicate device and engineering testing (e.g., biocompatibility testing per ISO 10993 for the adhesive). Functionality is demonstrated through the device's design and features, which are comparable to the predicate.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This document is for a physical medical device, not an AI model.

Summary

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K03020f

IMBIBE II Syringe 510(k) Notification Orthovita, Inc.

APR 1 6 2003

510(k) Summary

IMBIBE II Syringe

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley ParkwayMalvern, PA 19355	(610) 640-1775	Andreina IdeSr. Director, RegulatoryAffairs
April 2001
Trade Name	Subject Device		Predicate Device
	IMBIBE II Syringe		IMBIBE Bone MarrowAspiration Syringe
Common Name	Bone Graft/Bone Void FillerDelivery Syringe		Bone Graft/Bone Void FillerDelivery Syringe
Classification Name	Piston Syringe		Piston Syringe

Device Description:

Fitting the male connector of a vacuum application device, such as a secondary empty I piston syringe.
. Fitting the male connector of a secondary pre-filled piston syringe containing bone marrow, autologous blood, plasma or other blood components.

Prior to use, the IMBIBE II syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). Two methods can be used to imbibe the bone void filler with bone marrow or autologous blood. Method I collects blood or marrow by way of a needle attached to the distal Luer-lock and vacuum/aspiration applied by way of a secondary syringe attached to the proximal Luer-lock. Method II fills the IMBIBE II Syringe through the proximal port (Luer-lock) with blood or marrow collected by way of a secondary syringe.

Once the desired volume of blood or marrow has been collected and mixed with the bone void filler, the secondary syringe and/or aspiration needle are removed. A pushrod is

G 01
-3

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KOSOLO 8 IMBIBE II Syringe 510(k) Notification Orthovita, Inc.

attached to the piston at the proximal end of the IMBIBE II Syringe by way of the female Luer-lock, the distal cap is unscrewed and the contents of the syringe are delivered to the surgical site by extruding the mixed bone void filler.

Intended Use:

The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

COMPARISON TO PREDICATETable I
	IMBIBE 11 Syringe	Predicates IMBIBE BoneMarrow AspirationSyringe NML1087
Syringe Type	Piston Syringe	Piston Syringe
Intended Use	To collect bloodcomponents/bone marrow formixing with bone graft andsubsequent delivery to thesurgical site.	To collect bloodcomponents/bone marrow formixing with bone graft andsubsequent delivery to thesurgical site.
Principle of Operation	Syringe used to collectblood, marrow Removable cap allowssyringe to be filled with graftmaterial Syringe provides for mixingof blood, marrow with graftmaterial Removable screw cap allowsfor delivery of blood,marrow filled graft tosurgical site Luer-lock (nozzle) at theproximal end of the barrelallows connection of asecondary piston syringe.	Syringe used to collect blood,marrow Removable cap allowssyringe to be filled with graftmaterial Syringe provides for mixingof blood, marrow with graftmaterial Removable screw cap allowsfor delivery of blood, marrowfilled graft to surgical site

Comparison to Predicate:

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K030208f

IMBIBE II Syringe
510(k) Notification
Orthovita, Inc.

Overall Length	3.5, 4.6, 3.9, 5.3 inches(respectfully for a 5cc, 10cc, 15cc, 30cc internal volume)	2.9 inches
Barrel Diameter	0.73, 0.73, 1.05, 1.05 inches, OD(respectfully for a 5cc, 10cc, 15cc, 30cc internal volume)	0.73 inches, OD
Tip Type	Gasket	Gasket
Volume	5, 10, 15, 30 cc	10 cc
Nozzle Type	Luer-lock	Luer-lock
Barrel Markings	Graduated scale	Graduated scale
Lubricant Composition	None	Silicone
Lubricant amt/cm²	Not Applicable	100mg ± 5mg
Barrel Transparency	Transparent, no radiopacifiers	Transparent, no radiopacifiers
Reuse	Single use only	Single use only
Biocompatibility	Established by way of legally marketed device, IMBIBE BoneMarrow Aspiration Syringe, K011087 and ISO 10993 testing of adhesive	Established
Materials	Polycarbonate, ABS, Silicone,Dymax UV adhesive 1187-M-T	Polycarbonate, ABS, Silicone
Labeling	See Exhibit B. Same as predicate except additional information regarding directions for use.	See Exhibit C
Sterility	Sterilized by gamma radiation	Sterilized by gamma radiation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2003

Ms. Andreina Ide Senior Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K030208

Trade/Device Name: IMBIBE II Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Codes: FMF Dated: January 17, 2003 Received: January 21, 2003

Dear Ms. Ide:

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. Iisting 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 (OS) 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 - Ms. Andreina Ide

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsmaldsmamain.html

Sincerely yours,

Miriam C. Provost

tot 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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INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: IMBIBE II Syringe

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Miriaml. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030208

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).