The Medimop Mixject with Spray Head device enables injection of a diluent into a drug vial connected to the Dispensing pin (Vial adapter), for reconstitution and aspiration of the reconstituted drug into a syringe attached to the luer-lock end of the body. The vial and the Dispensing pin (Vial adapter) can be removed by turning the Dispensing pin (Vial adapter). The removal of the Dispensing pin (Vial adapter) turns the turning core from the aspiration position to the fixed spray position allowing spray application / delivery of the drug onto the desired surface.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medimop Mixject with Spray Head device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria or a detailed table of device performance results against such criteria. Instead, it relies on a statement of substantial equivalence to predicate devices and general performance claims.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to effectively transfer drugs	Bench testing performed to demonstrate ability to effectively transfer drugs.
Ability to effectively mix drugs	Bench testing performed to demonstrate ability to effectively mix drugs.
Ability to effectively apply drugs (spray)	Bench testing performed to demonstrate ability to effectively apply drugs (spray).
Viscosity handling (up to 4.7 cP)	Indications for Use state "topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials." The device presumably met this capability.
Operates on the same principle as predicate devices	Stated in Section 7 as a basis for substantial equivalence.
No additional concerns regarding safety and effectiveness compared to predicates	Concluded in Section 9.

Study Information

Based on the provided document, the study conducted was a non-clinical bench test.

Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of devices tested, number of repetitions, etc.) for the bench tests.
- The data provenance is not explicitly stated in terms of country of origin, but the company is based in Israel, so it's likely the tests were conducted there or at a laboratory working with them. The study was non-clinical, meaning it focused on the device's physical performance rather than human subject data, so the "retrospective or prospective" designation isn't directly applicable in the typical clinical trial sense. It was a prospective bench study designed to evaluate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. As a non-clinical bench test, the "ground truth" would likely be established by engineering specifications, validated test methods, and potentially expert interpretation of results by engineers or scientists, rather than medical experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given that it was a bench test for a simple device, formal adjudication by multiple experts is unlikely to have been a primary methodology for determining test outcomes. Performance would be measured against pre-defined engineering criteria.
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:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often with AI assistance. The Mixject with Spray Head is a drug delivery and mixing device, not an imaging or diagnostic device, and thus an MRMC study is inappropriate and wasn't conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done in the form of "Bench testing" (non-clinical testing). The device performance was evaluated on its own merits and functionality (transfer, mixing, spray application) without human interaction specifically for the test. The device itself is designed for human use but the performance validation was done in a standalone manner for the device's technical capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's non-clinical bench testing would be based on engineering specifications, established physical and chemical principles, and validated measurement techniques. For example, drug transfer efficiency would be measured quantitatively, mixing effectiveness could be assessed by homogeneity measurements, and spray application characteristics (e.g., droplet size, spray pattern) would be measured against predefined operational parameters for a spray head. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
The sample size for the training set:
- This information is not applicable and not provided. This device is a mechanical medical device, not a machine learning or AI-based algorithm that requires a "training set."
How the ground truth for the training set was established:
- This information is not applicable and not provided. As mentioned above, there is no "training set" for this type of device.

Summary

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KI22023

ОСТ

Attachment 5

4 2012

510(k) Summary

1. Submitter Information

Submitter InformationName:	Medimop Medical Projects Ltd
Address:	17 Hatidhar St
	Ra'anana 4366519
	Israel
Telephone Number:	972-9-7778666
Fax Number:	972-9-7485916
Contact person:	Ilanit Goldgraber
	Director of RA
Telephone Number:	972-9-7778666 Extension 219
Fax Number:	972-9-7485916
E-mail:	ilanit.goldgraber@westpharma.com
US Agent:	Deborah M. Thomas
	West Pharmaceutical Services, Inc.
Address:	101 Gordon Dr.
	Lionville, PA 19341
Telephone Number:	(610) 594-3105
Fax Number:	(610) 594-3004
Email:	debbie.thomas@westpharma.com
Date Prepared:	05 July 2012
Device Name
Device Trade Name:	Mixject™ with Spray Head
Common Name:	Mixject with Spray Head
Classification name:	Syringe, Piston
Classification
Product Code:	FMF
Regulation No.:	880.5860
Class:	II
Panel identification:	General Hospital Panel
Predicate Devices
Predicate 1:	Mixject Dispensing Pin with Detachable Vial Holder
	(K963583)
Predicate 2:	Mixject Dispensing Pin with Detachable Vial Holder
	(K001293)
Predicate 3:	Laryngo-Tracheal Mucosal Atomization Device
	(MADGIC), (K002255)

02 October 2012

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5. Device description

6. Indications for use

Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

7. Technological Characteristics and Substantial Equivalence

The Mixject with Spray Head and has the same principle of operation as the predicate devices Mixject Dispensing Pin with Detachable Vial Holder (K963583) and (K001293) and the Laryngo-Tracheal mucosal Atomization Device (MADGIC) (K002255), described as the predicate devices and is therefore substantially equivalent to this devices.

8. Nonclinical Testing

Bench testing was performed to demonstrate the ability of the proposed Mixject with Spray Head to effectively transfer, mix and application of drugs contained in vials.

9. Conclusion

Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices. Any differences between the proposed and predicate devices do not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

OCT 4 2012

Medimop Medical Projects, Limited C/O Ms. Deborah M. Thomas West Pharmaceutical Services, Incorporated 101 Gordon Drive Lionville, Pennsylvania 19341

Re: K122023

Trade/Device Name: Mixject™ with Spray Head Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 9, 2012 Received: July 11, 2012

Dear Ms. Thomas:

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. Thomas

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,

For

B. P. Shette M.D.

Physician

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

Enclosure

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K122023

MixJect with Spray Head

Traditional 510(k)

Indications for Use

510(k) Number (if known):

Device Name: Mixject with Spray Head

Indications for Use:

Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1_ of 1

Richard C. Chapa 10/4/12

eneral Hospital

510(k) Number: K122023

02 October 2012

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).