The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication.

The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.

Device Description

The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank.

The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.

The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device, not an AI/ML medical device. The information requested (such as expert consensus, MRMC studies, or training set data) is typically relevant for evaluating AI/ML device performance and isn't provided in traditional medical device submissions like this.

However, I can extract the closest equivalent information from the given text based on how a traditional medical device's performance is demonstrated to meet its acceptance criteria.

Here's the analysis of the provided text in the context of your questions:

The submission K121270 is for the Biojector® 2000 Needle-Free Injection Management System to add a new Indication for Use for administering intradermal injections using an ID Spacer. The primary method of demonstrating acceptance is through non-clinical performance testing and a comparative animal study against predicates.

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

The acceptance criteria are primarily derived from the international standard ISO 21649:2006 for Needle-free injectors and biocompatibility/sterilization standards. For the intradermal indication, the performance is also evaluated against a needle and syringe and a predicate needle-free injector concerning specific injection characteristics.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (with ID Spacer)	Comparison/Outcome
General Performance	ISO 21649:2006	Met the performance requirements	Compliant
Dose Accuracy	-	± 5%	Meets accuracy
Biocompatibility	ISO 10993-5:2009 (Cytotoxicity)	Met established criteria	Compliant
	ISO 10993-10:2010 (Sensitization)	Met established criteria	Compliant
	ISO 10993-10:2010 (Irritation/Intracutaneous Reactivity)	Met established criteria	Compliant
Sterilization	ISO 11135:2007 (Ethylene Oxide Sterilization)	Met established criteria	Compliant
	ISO 10993-7:2008 (Ethylene Oxide Residuals)	Met established criteria	Compliant
Intradermal Injection Equivalence (Animal Study)	-
- Wheal Size	Substantially Equivalent to needle/syringe	Demonstrated substantial equivalence	Met criteria
- Depth of Penetration	Substantially Equivalent to needle/syringe	Demonstrated substantial equivalence	Met criteria
- Dye Dermal Contact Area	Substantially Equivalent to needle/syringe	Demonstrated substantial equivalence	Met criteria

2. Sample size used for the test set and the data provenance

Non-Clinical Performance Testing (ISO 21649:2006, Biocompatibility, Sterilization): The document does not specify the exact sample sizes for these tests (e.g., how many devices were tested for dose accuracy, how many samples for biocompatibility). These are typically standard tests with defined sample sizes per the respective ISO standards. The data provenance is from non-clinical laboratory testing presumably conducted by or for Bioject, Inc. (manufacturer).
Animal Studies: The text states, "Testing in an accepted porcine model was conducted." The exact number of animals or injections performed is not specified. The provenance is prospective animal (porcine) study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in this type of submission. Ground truth for device performance in this context is established through objective measurements (e.g., instrument readings for dose accuracy, histological analysis in animal studies) rather than expert human interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretation or clinical outcomes, which is not relevant to the non-clinical and animal studies described here.

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

This is not applicable. This is a submission for a mechanical medical device, not an AI device, so MRMC studies involving human readers with/without AI assistance are not relevant.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

For Non-Clinical Performance (e.g., Dose Accuracy, ISO 21649:2006): The ground truth is based on objective measurement standards and engineering specifications.
For Biocompatibility and Sterilization: The ground truth is based on defined biological responses or chemical analyses as per the ISO standards.
For Intradermal Injection Equivalence (Animal Study): The ground truth was established by direct observation and measurement within the porcine model for "wheal size, depth of penetration, and dye dermal contact area." This would likely involve histological analysis or other direct measurement techniques after injection.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device, and therefore does not have a "training set" in that context. The device's design and engineering would have involved iterative development and testing, but not in the sense of an AI training set.

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

This is not applicable for the same reason as above.

Summary

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K.121270

PREMARKET NOTIFICATION

JUL 19 2012

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

as required by section 21 CFR 807.92(c)

Date Prepared:

April 23, 2012

Submitted By:

Bioject, Inc. Christine Breitbach QA/QC/RA Manager 7180 SW Sandburg St., Suite 100 Tigard, OR, 97223, USA 503-692-8001 Phone 503-692-6698 Fax

Device Name:

Proprietary Name: Biojector® 2000 Needle-Free Injection Management System (B2000)

Common Name: Needle-Free Jet Injector

Classification Name: Injector, Fluid, Non-Electrically Powered 21 CFR 880.5430, Product Code KZE

Predicate Device(s):

Biojector® 2000 Needle-Free Injection Management System (K960373) Becton Dickinson Single Use Hypodermic and Insulin Syringe (K980580) Terumo America, Inc Disposable Hypodermic Needle (K771203)

PharmaJet 0.1 ml Needle-free Injector System (K110456)

Purpose of Submission: To add a new Indication for Use with the Biojector® 2000 to administer intradermal injections using the ID Spacer.

Device Description:

The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be

Biojector® 2000 ID Indication Traditional 510(k) Submission

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K12/270

deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters.

Intended Use:

Device Use:

A device operator (healthcare worker, or a patient/family member authorized by their practitioner), aseptically opens the sterile packaging and fills the syringe with a desired amount of liquid medication using the provided disposable vial adapter. The filled syringe is then loaded into the Biojector® 2000 with a clockwise twisting motion until completely seated and a green color is visible in the syringe interlock window. The actuation (trigger) interlock is disengaged and the device is ready for use. The operator presses the syringe (or ID Spacer for intradermal injections) onto the skin at a 90° angle in a location appropriate for the route of administration and the actuator is pulled back initiating the injection. Following the injection, the syringe (and ID Spacer if used) is discarded in a normal medical waste container. The device is ready for reloading and can perform approximately 10 injections per each new CO2 cartridge. The Biojector® 2000 can also be attached to a large capacity CO2 tank with an adapter to perform increased numbers of injections between gas source changes.

Non-Clinical Testing Summary

Performance:

The Biojector® 2000 Needle-Free Injection Management System including the Intradermal (ID) Spacer has been verified to meet the performance requirements of ISO 21649:2006, Needlefree injectors for medical use - Requirements and test methods.

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K121270$\varnothing$

Biological Safety:

The Bioject ID Spacer is a patient contact component and has been tested to, and met the established criteria for, the following biocompatibility requirements:

Cytotoxicity	ISO 10993-5:2009
Sensitization	ISO 10993-10:2010
Irritation/Intracutaneous Reactivity	ISO 10993-10:2010

The Biojector® 2000 disposables have patient and drug contact surfaces that are tested to, and met the established criteria for, the following biocompatibility requirements:

Cytotoxicity	ISO 10993-5:2009
Irritation/Intracutaneous Reactivity	ISO 10993-10:2010
Acute Systemic Toxicity	ISO 10993-11:2006
Haemocompatibility	ISO 10993-4:2002/Amd 1:2006

Sterilization:

The final packaged No. 2 Syringe with ID Spacer assembly has been tested to, and met the established criteria for, the following sterilization requirements: 、

Ethylene Oxide Sterilization	ISO 11135:2007
Ethylene Oxide Residuals	ISO 10993-7:2008

Animal Studies:

Testing in an accepted porcine model was conducted and demonstrated that intradermal injections performed using the Biojector® 2000 with an Intradermal Spacer or with a needle and syringe are substantially equivalent for the criteria tested: 1) wheal size, 2}, depth of penetration, and 3) dye dermal contact area.

Technological Comparison:

Characteristic	Biojector® 2000with ID Spacer	Biojector® 2000(IM & SC)	BD Syringe andTerumo Needle	PharmaJet 0.1ml NFI System
Actuation	Trigger	Trigger	Standard PistonSyringe & Needle	Trigger
Trigger Safety	Yes	Yes	NA	Yes
Power Source	CO2 gas	CO2 gas	Human	MechanicalSpring
Injector Life Cycle	33,000 injections	33,000 injections	NA	20,000 injections
MedicationTransfer	Vial Adapter	Vial Adapter	Hypodermicneedle	Vial Adapter
ISO 21649:2006Compliance	Yes	Yes	NA	Yes
Volume ofInjectate	0.1 ml only	0.1 ml to 1.0 ml	0.05 ml to 1.0 ml	0.1 ml fixed
Dose Accuracy	$\pm 5%$	$\pm 5%$	Unknown	$\pm 5%$

Biojector® 2000 ID Indication Traditional 510(k) Submission

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Characteristic	Biojector® 2000with ID Spacer	Biojector® 2000(IM & SC)	BD Syringe andTerumo Needle	PharmaJet 0.1ml NFI System
Orifice Diameter	0.004"	0.004", 0.006",0.008", 0.010",0.014"	NA	0.007"
Single UseDisposables	Yes	Yes	Yes	Yes
SterileDisposables	Yes	Yes	Yes	Yes
DisposableSterilizationMethod	EtO	EtO	Unknown	Electron Beam

Conclusion:

The Biojector® 2000 with the Intradermal Spacer has the same indications for use as the predicate devices and is substantially equivalent to the performance of the PharmaJet 0.1 ml Needle-free Injector System and the use of a needle and syringe for intradermal injections. The Biojector ® 2000 when used with the Intradermal Spacer does not raise any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Ms. Christine Breitbach OA/OC/RA Manager Bioject Medical Technologies, Incorporated 7180 SW Sandburg Street. Suite 100 Tigard, Oregon 97223

JUI 19 2012

Re: K121270

Trade/Device Name: Biojector® Needle-Free Injection Management System, Biojector® B2000 Regulation Number: 21 CFR 880.5430 Regulation Name: Non-electrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: April 24, 2012 Received: April 26, 2012

Dear Ms. Breitbach:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Breitbach

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Fx R. Shete
Pandit md

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

510(K) # (if known):

Device Name:

Biojector® Needle-Free Injection Management System, Biojector® B2000

Indications for Use:

The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lyl Wini for REC July 18, 2012

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

K1212-10(k) Number:

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).