This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.

Device Description

The Graft Delivery System will be configured using the following components. See Exhibit 1 for drawings and supplier catalog Information.

. Two commercially available disposable medical piston syringes
Applicator tips .
This Graft Delivery System will be sold in coniunction with CelSep® Centrifuge System (K994148), CelSep® Centrifuge System (K994148) that consists of a compact bench top centrifuge designed for multi-purpose use in medical, industrial, and scientific laboratories, that includes a single-use processing disposable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a "Graft Delivery System" (piston syringe). This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new, standalone device.

Therefore, the requested information (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) cannot be extracted from the provided document.

The document states:

"No performance standards have been developed for this type of device." (Page 1)
The primary method for clearance is establishing "Substantial Equivalence" to existing predicate devices (Page 2).

The core of the submission is a comparison table showing that the "Graft Delivery System" has the "Same" intended use, components, sterility, and principle of operation as its predicate devices (DePuy/AcroMed Symphony and Harvest Technologies SmartJet). The only difference noted for Osseous Technologies and DePuy AcroMed is the specific centrifuge system with which they are commercially available/labeled.

This type of submission focuses on demonstrating that the new device is as safe and effective as already legally marketed devices, rather than providing detailed performance studies against defined acceptance criteria.

Summary

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1 2002 JUL

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510(k) Notification

A. ADMINISTRATIVE INFORMATION

Applicant or Sponsor: Biomet, Inc. P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46582 (FDA registration no. 1825034)

Contact Person: Lonnie Witham Phone: (219) 267-6639 FAX: (219) 372-1683

Marketer/Distributor: Osseous Technologies, Inc., a Division of Biomet Orthopedics, Inc. P.O. Box 587 56 East Bell Drive Warsaw, IN 46582

Manufacturing Site(s):

Contract Manufacturer: MicroMed, Inc. 124 Heritage Avenue Portsmouth, NH 03801 (FDA registration no. 1220894) Specification holder: Implant Innovations, Inc., a Biomet Company 4555 Riverside Drive Palm Beach Gardens, FL 33410 (FDA registration no. 1038806)

в. DEVICE IDENTIFICATION

Proprietary Name: Graft Delivery System

Common or Usual Name: Piston Syringe

Classification Name: Piston Syringe

Device Classification: 21 CFR 880.5860 Piston Syringe - Class II

Device Product Code: FMF

Performance Standards/Guidance Documents: No performance standards have been developed for this type of device.

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Previous FDA Status: Per 21 CFR 880,5860 the device is Class II and may be cleared for marketing with a pre-market notification under section 510(k),

C. DEVICE DESCRIPTIVE INFORMATION

Intended Use: This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.

Device Description: The Graft Delivery System will be configured using the following components. See Exhibit 1 for drawings and supplier catalog Information.

. Two commercially available disposable medical piston syringes
Applicator tips .

This Graft Delivery System will be sold in coniunction with CelSep® Centrifuge System (K994148), CelSep® Centrifuge System (K994148) that consists of a compact bench top centrifuge designed for multi-purpose use in medical, industrial, and scientific laboratories, that includes a single-use processing disposable.

Materials: Materials for the Graft Delivery System meet the requirements set forth in the current U.S. Pharmacopeia for Class IV and Class VI as well as the FDA modified ISO 10993-1 tests for biocompatibility for human body fluid of 30 days or less. Components are manufactured from medical grade resins.

Labeling: Sample labels and labeling are included in Exhibit 2.

Sterility Information: The Graft Delivery System consists of a 60cc Becton Dickinson disposable sterile syringe and a 10cc Becton Dickinson disposable sterile syringe. The devices are procured packaged and sterile, and will retain the original individual sterile package and labeling as provided from the Becton Dickinson. These same sterile disposable syringes were previously cleared for use in the processing disposable kit for the CelSep® Centrifyge System (K994148). Becton Dickinson has several premarket notifications cleared for marketing of piston syringes including K930321. K95064, and K980580. The two individual sterile packages will then be organized into a convenience pack by placing them in a rigid blister tray with a sealed Tyvek® lid. The outer lid of the kit will bear an Osseous Technologies label.

Packaging Description: A description of the packaging is in Exhibit 2. 00005

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Substantial Equivalence: The Graft Delivery System is substantially equivalent to the DePuy/AcroMed Symphony Graft Delivery System (K003286), a J &J Company, the Harvest Technologies SmartJet Bone Grafting Liquid Applicator (K011032), and the MicroMedics FibriJet Aerosol Applicator (K012868). See Exhibit 3 for predicate devices.

Summary ComparisonOsseous Tech., Symphony, and MicroMedics Delivery Systems
Characteristic	Osseous	DePuy AcroMed	Micromedics
	Technologies	Symphony(K003286)	FibriJet
	(This submission)	Harvest Tech.SmartJet(K011032)	(K012868)
Intended Use	Delivery of allograft,autograft toorthopedic surgicalsite and facilitatepre-mixing of bonegraft with I.V. fluids,bleed, plasma,platelet rich plasma,bone marrow orother specific bloodcomponents asdeemed necessaryby the clinical userequirements.	Same asOsseous Tech.	For simultaneousdelivery of twonon-homogenousliquids to thesame area.
Components	Commerciallymarketed pistonsyringes andapplicator tips instraight and sprayconfigurations	Same asOsseous Tech.	Same asOsseous Tech.
LabelingIncludesCommerciallyAvailableCentrifuge	CelSep® CentrifugeSystemK994148	SmartPrepCentrifugeSystemK991430	None Known
Sterility	Sold Sterile - Singleuse - Disposable	Same asOsseous Tech.	Same asOsseous Tech.
Principle ofOperation	Fluids dispensedfrom the applicatortip by depressingthe syringeplunger(s)	Same asOsseous Tech.	Same asOsseous Tech.

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D. SUMMARY OF SAFETY AND EFFECTIVENESS

A summary of information pertaining to the safety and effectiveness of this type of device is contained in Exhibit 4 for Summary of Safety and Effectiveness.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircling the image. The text is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2002 JUL

Biomet. Inc Lonnie Witham P. O. Box 587 Warsaw, Indiana 46581 - 0578

Re: K021071

Trade Name: Graft Delivery System Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 25, 2002 Received: April 2, 2002

Dear Mr. Witham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Lonnie Witham

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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), 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/dsma/dsmamain.html

Sincerely yours,

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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Page 1 of 1

510(k) Number: |( 02/07/

Device Name: Graft Delivery System

Indications For Use: This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.
(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 (Optional Format 1-2-96)

(Option

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

510(k) Number K021071

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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).