The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® 2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector@ 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

Device Description

The Biojector® 2000 is a needle free injection management system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the bodv. The system is comprised of three major components: The single use sterile medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.

The syringe holds a variable volume of drug up to a maximum of one cubic centimeter (cc) or milliliter (ml.). Volume increments are marked at 0.10, 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.75, 0.80, 0.90, and 1.0 cc or ml. The syringe is filled using either a fill needle, or a plastic fluid transfer device. Once the syringe is filled, it is loaded in the Biojector®. Syringes are available in five sizes which are numbered 2, 3, 4, 5 and 7. The syringe sizes have the following orifice diameters: 0.004, 0.008, 0.010 & 0.014 inches, respectively. The number 2 syringe is used for all subcutaneous injections. The remaining syringes, numbered 3, 4, 5, and 7, are used for intramuscular injections. Depth of penetration of the drug varies with the orifice diameter selected. The larger the orifice diameter, the deeper the penetration of the drug.

Activation of the Biojector® is initiated when the actuator is depressed. CO2 gas is released. through the action of a series of valves within the injector. This causes the plunger to push the drug out of the sterile syringe, through the syringe orifice at a high velocity, allowing it to penetrate the skin and be deposited in the tissue. Exhaust CO2 is expelled, through the exhaust and bleed valves, in the rear section of the Biojector®, as well as into the cartridge compartment. The CO2 does not come in contact with the drug.

AI/ML Overview

This 510(k) summary describes modifications to the Biojector 2000 device, asserting its substantial equivalence to a previously cleared predicate device (K920631). As such, the document focuses on demonstrating that the modified device is as safe and effective as the predicate without introducing new safety or efficacy issues.

Here's an analysis of the provided information relevant to acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance	Study Type/Evidence
Functional Equivalence	Deliver subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs.	The Biojector® 2000 (modified device) is found to be functionally equivalent to the predicate device in delivering SC and IM injections.	Product qualification testing and biocompatibility data compared to the predicate device.
Material Changes	New plastic parts and alternate vendors for existing materials must not negatively impact performance or safety.	Performance and safety are maintained despite material changes.	Product qualification testing and biocompatibility data.
CO2 Efficiency & Performance	Improved CO2 efficiency and performance of exhaust and bleed valves.	Modifications to exhaust and bleed valves improve CO2 efficiency and performance.	Implied by the statement of modification and the overall functional equivalence claim.
Safety & Effectiveness	No new safety and efficacy issues compared to the predicate device. The device is as safe and effective.	No new safety and efficacy issues were raised. The device is as safe and effective as the predicate.	Product qualification testing and biocompatibility data. Comparison of intended use, labeling, design, materials, and operational principle to the predicate device.
Intended Use	Maintain the same intended use as the predicate device (delivery of SC or IM injections by various practitioners and authorized patients).	No changes in intended use.	Comparison of intended use to predicate device.
Operational Principle	Maintain the same operational principle as the predicate device.	No changes in operational principle.	Comparison of operational principle to predicate device.

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

This document does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "Product qualification testing and biocompatibility data," which are general categories and not detailed clinical studies with specific test sets in the traditional sense. It's likely that "test set" here refers to a set of devices or components undergoing engineering and biocompatibility evaluations, not human subjects.

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

This information is not provided in the document. Given that the focus is on device modification and functional equivalence to a predicate, "ground truth" would likely relate to engineering specifications and performance metrics rather than clinical diagnoses.

4. Adjudication Method for the Test Set

This information is not provided. Since the studies appear to be primarily engineering and biocompatibility assessments, a traditional adjudication method for human subject data is not applicable here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this document. The submission focuses on substantial equivalence based on material and design modifications, not on improved human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone (algorithm only) performance study was not done. The Biojector 2000 is a physical medical device for drug delivery, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context would implicitly be defined by:

Engineering Specifications: Performance parameters (e.g., injection pressure, drug delivery volume accuracy, CO2 efficiency, depth of penetration for different syringe sizes) set during the design and manufacturing of the device.
Predicate Device Performance Data: The known and accepted performance characteristics of the legally marketed predicate device (Biojector® 2000 Jet Injection System, K920631).
Biocompatibility Standards: Established standards for materials that come into contact with the patient.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this particular submission, as it's a modification of an existing device seeking substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As noted, this is not an AI/algorithm-based device that would require a "training set."

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

This information is not applicable and not provided for the same reasons mentioned in point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1997

Mr. Mary K. Norton Manager, Regulatory Affairs/Quality Assurance Bioject, Incorporated -----7620 S.W. Bridgeport Road 97224 Portland, Oregon

K960373 Re : Biojector 2000 Needle-Free Injection Trade Name: Management System Regulatory Class: II Product Code: KZE December 5, 1996 Dated: Received: December 6, 1996

Dear Ms. Norton:

We have reviewed your Section 510(k) notification of intent to we have reviewed your becases be have have determined the market the device referenced above the indications for device Is substancially equivaler (and in the enclosed in interstate use stated in the encreases, so the enactment date of the commerce prior to nay be , or to devices that have been Medical Device Amendically, of the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore), rood, brag, and Coomeric not the general controls provisions The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requirementacturing practice, labeling, and devices, good manazaomisbranding and adulteration.

If your device is classified (see above) into either class II il your device is class III (Premarket Approval), it may (Special Controls) of the mal controls. Existing major be subject to such adable device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A Federal Regulations, freic arr instion assumes compliance with substantially equivalent actice for Medical Devices: General the Good Manufacturing Prascros o) and that, through periodic (GMP) regulacion (2) erk Fard Orug Administration (FDA) will GMF Inspections) Failure to comply with the GMP verly such assumpeloni. regulatory action. In addition, FDA may publish further announcements concerning your device in may publish farenes and es this response to your the reactar Region submission does not affect any premarked nocersight have under sections 531 through 542 of

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Page 2 - Ms. Norton

the Act for devices under the Electronic Product Radiation the Act for devices ander one beeral laws or regulations.

This letter will allow you to begin marketing your device as Info recei will arrow ) premarket notification. The FDA described in your sitem privalence of your device to a legally finding of subbeancear equresults in a classification for your marketed predicate acvice pour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulation (ar c devices), please contact the Office of Vicio draghobere at (301) 594-4618. Additionally, for questions on Compriance at (501) Sectising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to enc regaracton" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on Journaion of Smail Manufacturers Assistance obtained from the British on 63-2041 or at (301) 443-6597.

Sincerely yours,

Timothy A. Ulatowski

Timot Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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510(k) Number (if known) K960373

Device Name: Biojector® Needle-Free Injection Management System, Biojector® 2000

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) fallice Division of Dental, Infection Control and General Hospital Device

General Hospital Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over The-Counter Use

Optional Format 1-2-96)

011-1

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K960373

January 24, 1996

MAR - 5 1997

BIOJECT INC.
7620 S.W. BRIDGEPORT ROAD
PORTLAND, OREGON 97224
TELEPHONE: (503) 639-7221
FAX: (503) 624-9002

510(k) SUMMARY (21CFR Subpart 807.92)

(a)(1) Submitter Identification:

Bioject, Inc. 7620 SW Bridgeport Road Portland, OR 97224 800-683-7221 503-624-9002 (fax)

Contact Person: Mary K. Norton Manager, Regulatory Affairs/Quality Assurance

(a)(2) Device Name:	Biojector® 2000 Needle-Free Injection Management System™
Common Name:	Needleless Injector, Jet Injector
Classification Name:	Non-electrically Powered Fluid Injector, 21 CFR 880.5430

Biojector® 2000 Jet Injection System (K920631) (a)(3) Predicate Device:

The Biojector® 2000 is a needle free injection management (a)(4) Device Description: system designed to deliver drugs both subcutaneously (SC) and intramuscularly (IM). It is a non-electrically powered device which is intended to administer an injection by means of a high velocity jet of fluid that penetrates the surface of the skin and delivers drug to the The system is comprised of three major components: The single use sterile bodv. medication syringe (medication container), the Biojector® (injector), and the Carbon Dioxide (CO2) cartridge (power source). The device is also capable of being powered with a CO2 tank with a specialized adapter.

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(a)(5) Intended Use: The Biojector® 2000 Needle-Free Injection Management System™ which is the subject of this submission and the currently marketed (predicate) Biojector® 2000 Jet Injection System (with tank adapter), K920631, are intended to deliver subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable medications. Both the Biojector® 2000 (subject of submission) and the predicate device may be used by physicians, nurses, veterinarians, and podiatrists and other practitioners who routinely administer injections. The Biojector® 2000 (subject of submission) may also be used by patients authorized by their physicians to self inject at home, or have other individuals administer injections of prescribed drug. It should be noted that a prior submission made by Bioject (K861687), predicate to K920631, was cleared via the 510(k) process for professional and home use.

(a)(6) This Premarket Notification describes modifications to the Biojector® 2000 device previously described via the 510(k) process (K920631). A summary of these modifications includes:

. Changing from a two piece to a one piece main body design with related minor design changes to ease manufacturing:
. Incorporation of design modifications to the exhaust and bleed valves to improve CO2 efficiency and performance:
Changes in material involved replacing metal parts with plastic parts for cost reduction . purposes and to add alternate vendors for existing materials;
. Labeling revisions including the addition of a Home Use Instruction Manual.

There are no changes in intended use or operational principle. Substantial equivalence is based upon equivalence in intended use, labeling, design, materials and operational principle to the Biojector® Jet Injection System (with tank adapter). K920631 and there are no new safety and efficacy issues as a result of the design modifications.

Product qualification testing and biocompatibility data for the modified device (subject of submission) and the current, predicate device (K920631), demonstrate the new model to be functionally equivalent to the predicate device. The device is as safe and effective as the legally marketed, predicate device, and does not raise questions of safety and efficacy different than that of the predicate.

Regulation Number and Section

§ 880.5430 Nonelectrically powered fluid injector.

(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).