The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Vented Vial Adapter Transfer Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study related to strict acceptance criteria and performance metrics in the way one might for a diagnostic AI device.

Therefore, many of the requested categories for AI device studies (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable to this type of medical device submission.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the Vented Vial Adapter Transfer Device

The "acceptance criteria" for this device, within the context of a 510(k) submission, are primarily focused on demonstrating substantial equivalence to already cleared predicate devices regarding its intended use, technological characteristics, and safety and effectiveness. The "study" proving this largely relies on comparisons, material testing, and manufacturing quality controls.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated through Equivalence)	Reported Device Performance / Justification
Indications for Use: Transferring and mixing drugs contained in vials.	Met: "The Vented Vial Adapter Transfer Device has Indications for Use similar to the predicate devices – all are intended for transferring and mixing drugs and diluents contained in vials."
Technological Characteristics: Similar design principle, specifically enabling direct passage to and from vials in a sterile manner, and allowing connection to standard luer accessories.	Met: "All products have piercing spikes, which enable the users to create a direct passage to and from vials, in a sterile manner." "The Vented Vial Adapter Transfer Device allows the connection any standard accessory with a luer connection to be connected to a vial."
Material Safety (Biocompatibility): Materials suitable for intended use.	Met: "The Vented Vial Adapter Transfer Device is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP V1 requirements and were determined suitable for the Indications for Use of this product."
Sterility: Packaged sterile.	Met: "All devices are packaged sterile..." (mentioned for the predicate devices and implied for the proposed device through equivalence).
Safety and Effectiveness (General): No new issues of safety and effectiveness compared to predicates.	Met: "The Vented Vial Adapter Transfer Device is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness." This is supported by the technological comparison and the fact that "All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing, visual examination (in-process and finished product)."
Ergonomics: Designed ergonomically.	Met: Mentioned for predicate devices ("All devices are... designed ergonomically.") and implied for the proposed device through equivalence.

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

Not Applicable (N/A): This submission is for a medical device, not an AI/diagnostic software. There isn't a "test set" in the sense of a dataset for algorithm evaluation. Instead, the "testing" refers to manufacturing quality control and material biocompatibility.
Data Provenance: The device is manufactured by Medimop Medical Projects Ltd. in Ra'anana, Israel. The material testing (ISO 10993-1 and USP V1) would generate data, but specific details on the provenance of these material tests beyond the standards themselves are not provided. The comparison is retrospective to existing predicate devices.

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

N/A: Not relevant for this type of device submission. Ground truth as typically understood for AI models is not established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: Not relevant for this type of device submission.

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

N/A: Not relevant for this type of device submission. This is a physical medical device.

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

N/A: Not relevant for this type of device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A (Indirectly): The "ground truth" for this type of device is implicitly the established safety and effectiveness of its predicate devices, as well as adherence to recognized material and manufacturing standards (ISO 10993-1, USP V1, internal release specifications). The FDA's substantial equivalence determination acts as the validation.

8. The sample size for the training set

N/A: Not relevant for this type of device submission.

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

N/A: Not relevant for this type of device submission.

Summary

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K062482 page lot 3

17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com

Image /page/0/Picture/2 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters "MOP" in large, bold font, with a textured globe-like image placed within the "O". Below the large letters, the word "MEDIMOP" is printed in a smaller, sans-serif font, and below that is the text "MEDICAL PROJECTS Ltd." in an even smaller font.

NOV – 3 2006

510(k) summary for the VENTED VIAL ADAPTER TRANSFER DEVICE

(as required by section 807.92)

510(k) Notification submitted by:	Medimop Medical Projects Ltd.17 Hatidhar St.P.O. Box 2499Ra'anana 43665IsraelPhone: +972 (9) 7757122Fax: +972 (9) 7485916
Contact person:	Ari Y. SobelDirector, Quality and Regulatory Affairs
Date Summary Prepared	July 18, 2006
Trade Name:	Vented Vial Adapter Transfer Device
Classification name:	General Hospital Class II, 80LHIPer 21 CFR 880.5440 Intravascular administration set
Common device name:	Same as Trade name
Predicate devices:	MIXJECT® DISPENSING PIN510(k) No. K963583Medimop Medical Projects Ltd.MIXJECT® DISPENSING PIN510(k) No. K001293Medimop Medical Projects Ltd.MIX2VIAL TRANSFER DEVICE510(k) No. K031861Medimop Medical Projects Ltd.CHEMO MINI SPIKE PLUS510(k) No. K983794B. Braun IncorporatedTAKY SPIKE PLUS510(k) No. K974198Clinico
Manufacturer:	Medimop Medical Projects Ltd.17 Hatidhar St.P.O. Box 2499Ra'anana 43665Israel

pp 10, 1 of 3
Appendix 10

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Image /page/1/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters 'M' and 'P' in a bold, sans-serif font, with a crescent moon-like shape in between them. Below the letters, the word 'MEDIMOP' is written in a smaller, sans-serif font, and below that, the words 'MEDICAL PROJECTS Ltd.' are written in an even smaller, sans-serif font.

KO62482

17 Hatidhar St., P.O.B 249 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com

Material:

The Vented Vial Adapter Transfer Device is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP V1 requirements and were determined suitable for the Indications for Use of this product.

Device Description:

Indications for Use:

The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.

Technological comparison to Predicate Device:

The Vented Vial Adapter Transfer Device has Indications for Use similar to the predicate devices – all are intended for transferring and mixing drugs and diluents contained in vials. All products have piercing spikes, which enable the users to create a direct passage to and from vials, in a sterile manner.

The Vented Vial Adapter Transfer Device allows the connection any standard accessory with a luer connection to be connected to a vial. Once mixing of the diluent and the drug is complete the drug solution is ready for use and may be aspirated into an accessory (e.g. syringe). This is similar to Medimop's Mixject dispensing pin (K963583). The adapter vial assembly is a single use device and should be disposed of after use.

All devices are packaged sterile and designed ergonomically. A filter may be included, so as to assure purity of the dissolved drug prior to its injection.

Any differences between the Vented Vial Adapter Transfer Device solution and the equivalent devices have no significant influence on safety or effectiveness.

Safety and Effectiveness:

All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing, visual examination (in-process and finished product).

App 10. 2 of 3
Appendix 10

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Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text "K062482" is on the left side of the image, and the text "page 3 of 3" is on the right side of the image. The text appears to be written in black ink.

Image /page/2/Picture/1 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters "MOP" in a bold, sans-serif font, with a stylized globe or sphere design incorporated into the letter "O". Below the letters, the word "MEDIMOP" is printed in a smaller font, and below that, the words "MEDICAL PROJECTS Ltd." are printed in an even smaller font.

17 Hatidhar St., P.O.B 2499 Ra'anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com

Conclusion:

It is our conclusion that the Vented Vial Adapter Transfer Device and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging.

The Vented Vial Adapter Transfer Device is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness.

App 10, 3 of 3
Appendix 10

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ari Y. Sobel Director, Quality & Regulatory Affairs Medimop Medical Projects, Limited 17 Hatidhar Street P.O. Box 2499 Ra'anana 43665 ISRAEL

NOV - 3 2006

Re: K062482

Trade/Device Name: Vented Vial Adapter Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: August 15, 2006 Received: August 24, 2006

Dear Mr. Sobel:

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 8010 tarter addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Sobel

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.

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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) Number (if known):

Device Name: Vented Vial Adapter Transfer Device

Indications for Use: Transfer and Mixing of drugs 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)

Antony U. m

f Anascheciology, General Hospital, Control, Dental Devices

K062482

Page _ of _

CONFIDENTIAL Medimop Medical Projects Ltd.

VENTED VIAL ADAPTER TRANSFER DEVICE: 510(K) Submission August 15, 2006

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.