This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only.

Device Description

The Bi-3M Needle-Free Injector System consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.

AI/ML Overview

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Acceptance Criteria and Study for the Bi-3M Needle-Free Injector System

The provided document describes performance and safety tests conducted to demonstrate substantial equivalence of the Bi-3M Needle-Free Injector System to predicate devices, particularly the Ped-O-Jet. The primary focus of the studies was on dosage accuracy and prevention of cross-contamination.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined "acceptance criteria" as pass/fail thresholds for the performance tests. Instead, it compares the Bi-3M's performance directly to the predicate device (Ped-O-Jet) to demonstrate substantial equivalence. For the cross-contamination study, it reports a specific clean sample rate.

Performance Parameter	Acceptance Criteria (Implied by comparison)	Reported Bi-3M Performance
Dosage Accuracy	No significant difference compared to Ped-O-Jet	No significant difference between Bi-3M and Ped-O-Jet
Penetration	Similar to Ped-O-Jet	Similar to Ped-O-Jet
Focus	Similar to Ped-O-Jet	Similar to Ped-O-Jet
Force	Similar to Ped-O-Jet	Similar to Ped-O-Jet
Stream Quality	Similar to Ped-O-Jet	Similar to Ped-O-Jet
Environmental Stability	Consistent functionality at temperature extremes and after free fall	Indicated consistent functionality
Noise Level	Below OSHA exposure limits	Below OSHA exposure limits
Cross-Contamination Prevention	Designed to significantly reduce cross-contamination	99.8% clean sample rate (vs. 54% for Ped-O-Jet in high-contamination model)

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

Sample Size for performance tests (Dosage Accuracy, Penetration, Focus, Force, Stream Quality): The document does not specify the exact sample sizes used for these tests. It generally states a "battery of performance testing was done."
Sample Size for Cross-Contamination Safety Test: The document does not explicitly state the number of injections or replicates performed in the cross-contamination study, but it refers to "the one Bi-3M sample for which fluorescein was reported in the downstream collection," implying multiple samples were tested.
Data Provenance: The document does not explicitly state the country of origin. The organization (Felton International, Inc.) is based in Lenexa, Kansas, USA, so it's likely the testing was conducted in the USA or supervised by this entity. The study appears to be prospective as it was designed to test the Bi-3M device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for any of the reported tests. The performance and safety tests appear to be laboratory-based, objective measurements (e.g., measuring fluorescein, mechanical properties).

4. Adjudication Method for the Test Set

None. Since expert-defined ground truth or human interpretation is not indicated, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This device is a physical medical device (injector), not an AI diagnostic tool.

6. Standalone Performance

Yes. The document details standalone performance tests for the Bi-3M device. These tests evaluate the device's inherent mechanical function (dosage accuracy, penetration, etc.) and its ability to prevent cross-contamination, independent of human interaction in the outcome assessment (beyond operating the device). The results for dosage accuracy, penetration, focus, force, stream quality, environmental testing, noise level, and the 99.8% clean sample rate in the cross-contamination study represent its standalone performance.

7. Type of Ground Truth Used

Objective Laboratory Measurements: The ground truth for the performance tests (dosage accuracy, penetration, focus, force, stream quality, environmental, noise) was established through direct, quantifiable physical or mechanical measurements comparing the Bi-3M to the Ped-O-Jet.
Fluorescein Detection: For the cross-contamination study, the ground truth was the presence or absence of fluorescein (a chemical marker) in the downstream collection vessel, indicating contamination. This is an objective, laboratory-based detection method.

8. Sample Size for the Training Set

Not applicable. This document describes the testing and 510(k) submission for a physical medical device. It does not involve a machine learning algorithm or an "AI" device that would typically have a training set in the computational sense. The "training" of the device would refer to its engineering and design, not an ML model.

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

Not applicable. As noted above, there is no "training set" in the context of machine learning for this physical device. The device's design and manufacturing are based on engineering principles and previous iterations (e.g., the Bi-3 injector).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Felton International. The logo features a stylized "fi" in a bold, black font. To the right of the "fi" is the word "Felton" in a slanted, serif font, with the word "INTERNATIONAL" underneath in a smaller, sans-serif font.

013256 Ke | of 3

3210 Marshall Drive, Lenexa, KS 66214 U.S.A. 913-599-1590 FAX 913-599-0909 1-800-448-8522 Email: fi@feltonint.com

3. 510(k) SUMMARY

DEC 0 7 2001

A. Submitter Information:

Name:	Felton International, Inc.
Address:	8210 Marshall DriveLenexa, KS 66214
Phone:	(913) 599-1590
FAX:	(913) 599-0909
E-mail:	fi@feltonint.com
Contact:	Alan Felton, President
Date:	September 28, 2001
B. Device Information:
Trade/Proprietary Name:	Bi-3M Needle-Free Injector System
Common Name:	Needle-free fluid injector system
Classification Name:	Nonelectrically powered fluid injector (Title 21 CFR§880.5430)
Predicate Devices:	Ped-O-Jet (preamendment device)

C. Description of the Device:

MEDiVAX (K945548)

The Bi-3M Needle-free Injector System is identical to the Bi-3 injector which was first introduced into the public health system in Russia in 1974. Five modifications are made to the Bi-3M, the subject device of this submission. Three modifications to the injector are as follows: 1) the injected volume is fixed at 0.5 mL, whereas the Bi-3 can adjust to variable volume delivery (0.1 to 1.0 mL); 2) the device has a single nozzle for subcutaneous delivery, whereas the Bi-3 has three nozzle attachments for subcutaneous, intramuscular, and intradermal delivery; 3) a vial mount assembly holds the vial in place with a vial cap mount, whereas the original Bi-3 has metal clamps to hold the vial in place.

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The fourth and fifth modifications were made for the most significant feature of the Bi-3M needle-free injector system: the presterilized, single-use protector cap, and a redesign of the distal end of the hand unit to accommodate the cap. The cap is attached to the injector head before each injection and automatically removed before the next injection to prevent cross-contamination. All five modifications do not alter the basic mechanics of the device, or any component or aspect of the fluid path. The effectiveness in preventing cross-contamination is documented in the safety study discussed under Section 7.B.

D. Intended Use of the Device

The Bi-3M is designed to administer vaccines or medicines to the subcutaneous tissue by penetrating the skin under high pressure. It is intended for high-workload multiplepatient use by a health care professional, such as in mass immunization programs.

E. Technological Characteristics in Comparison to Predicate Devices

Similar to the Ped-O-Jet and MEDIVAX devices, Bi-3M is a needle-free injector system that consists of a hand-held injector unit and a connecting power source that is activated by a foot pump. The Bi-3M uses hydraulic fluid, which is identical to the power source of the Ped-O-Jet; MEDiVAX is powered by compressed air. All three devices hold a manufacturer's multiple-dose vial in position on the hand unit. A vial mount assembly that locks the vial cap to the Bi-3M hand unit holds the medicine vial in position. A 'U'-shaped clamp holds the vial cap in position on the Ped-O-Jet unit. The vial is attached first to a removable vial holder that is attached to the hand unit of MEDiVAX. The delivery of medication from the vial to the primary container in the hand unit is through stainless steel in all three devices. A presterilized protector cap is placed on the nozzle end of the Bi-3M before each injection to prevent cross-contamination; this cap is automatically removed after each use. MEDiVAX has a removable protector shield for the same purpose. No protective feature is on the preamendment Ped-O-Jet device.

All three devices have removable injector heads to facilitate cleaning and sterilization of the components in contact with the medication fluid path and human skin. These components require steam sterilization before each injection session. I 1

F. Nonclinical Performance Tests

A battery of performance testing was done to assess the substantial equivalency of the Bi-3M to Ped-O-Jet. Based on results of testing for dosage accuracy, there was no significant difference between the two injectors. Penetration, focus, force, and stream quality tests showed the two devices to be similar in these parameters. Additionally, environmental testing that tested the Bi-3M at temperature extremes and after free fall indicated consistent functionality. Operation of the Bi-3M produces sound that is below the exposure limits set by OSHA.

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G. Safety Tests

The effectiveness of the Bi-3M to prevent cross-contamination was tested with an in vitro model designed to produce a high probability of contamination. In this study, an injection was made first into a contaminated (fluorescein) fixture, then into a clean vessel to assess the downstream contamination. The results showed the Bi-3M had a 99.8% clean sample rate, whereas Ped-O-Jet had a 54% clean sample rate. The one Bi-3M sample for which fluorescein was reported in the downstream collection did not have any fluorescein evident in the protector caps, which indicates that the fluorometer reading was an error. The high clean sample rate by the Bi-3M in this study that was designed to have a high rate of contamination is indicative that cross-contamination is unlikely with this device.

H. Conclusions:

The Bi-3M injector system is designed similarly to the cited predicate devices. Based on the results of the performance tests for dose accuracy, penetration, focus, force, and stream quality, the Bi-3M has demonstrated substantial equivalence to the Ped-O-Jet predicate device. Furthermore, the results of the safety test demonstrated a high level of safety relative to cross-contamination.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Mr. Alan Felton President Felton International, Incorporated 8210 Marshall Drive Lenexa, Kansas 66214

Re: K013256

Trade/Device Name: Bi-3M Needle Injector System Regulation Number: 880.5430 Regulation Name: Needle-Free Fluid Injector System Regulatory Class: II Product Code: KZE Dated: September 28, 2001 Received: October 1, 2001

Dear Mr. Felton:

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.

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Page 2 - Mr. Felton

You must comply with all the Act's requirements, including, but not limited to: registration You must collibry with an the Fict 5 requirements, and 801); good manufacturing practice and listing (21 CFR Part 067), lacelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality ijon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ochi marketing your substantial equivalence of your device to 310(k) premiented 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 II you desire specific at not 2009.10 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 301) 594-4618. Additionally, for questions on the promotion and Office of Colliphance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, product note are rogan 2019 - Other general information on your responsibilities under notheation (21 OF ICP of It is on the Division of Small Manufacturers, International and the Act may be obtained 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,

Timothy A. Ulatowski

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

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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Applicant: Felton International, Inc.

Device Name: Bi-3M Needle-free Injector System

2. INDICATIONS FOR USE

Patrizia Cucurachi

IDivision Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Boital Devices 510(k) Number_Kal

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).