The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Device Description

The proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit thereby eliminating the need for a separate holder. The operating principle remains the same. The modified syringe holder accessory can still be used with both empty and prefilled (not the subject of this 510(k) application) Carpuject® Syringe Cartridges. The proposed name for this modification is the iSecure Syringe Cartridge Holder.

AI/ML Overview

The provided text is a 510(k) summary for the iSecure Syringe Cartridge Holder. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, most of the information requested in your prompt is not available in this document.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

The document does not specify any quantitative acceptance criteria or numerical performance metrics for the iSecure Syringe Cartridge Holder. The "performance" described is largely qualitative, asserting that it functions the same as the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The 510(k) relies on a comparison to a predicate device and does not detail specific new performance testing data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available. No such expert-verified test set is described.

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

This information is not available. No test set requiring adjudication is described.

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

An MRMC study was not done, as this device is a syringe cartridge holder, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" is not applicable here.

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

A standalone performance study was not done in the context of an algorithm. This device is a mechanical holder, not a software algorithm.

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

The concept of "ground truth" as typically applied to performance studies (especially for AI or diagnostic devices) is not applicable here. The substantial equivalence is based on the device's design and intended use being the same as the predicate.

8. The sample size for the training set

This information is not available. There is no "training set" as this is not an AI/machine learning device.

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

This information is not available. As above, no training set or ground truth in that context exists for this device.

Summary of available information regarding substantial equivalence (not a performance study):

The 510(k) summary for the iSecure Syringe Cartridge Holder focuses on demonstrating substantial equivalence to a predicate device, the Empty Sterile Carpuject® Cartridge Syringe holder Accessory.

Basis for Equivalence: The claim for substantial equivalence is based on the following technological characteristics:
- Both devices are intended to be used with either empty or prefilled Carpuject cartridges.
- The technology and operating principles are the same for both devices.
- The plunger rod for both devices is attached to the end of the syringe cartridge to actuate an injection.
Proposed Change: The only proposed change is to combine the Carpuject® cartridge and holder into one preassembled unit, eliminating the need for a separate holder. The operating principle, however, remains the same.

Therefore, while the document confirms the device meets the regulatory requirement for substantial equivalence, it does not provide the details of a quantitative performance study with specific acceptance criteria that you have requested.

Summary

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KO63180

510(k) SUMMARY

1.	Submitted by:	Hospira, Inc.D-389, Bldg. H2275 N. Field DriveLake Forest, IL 60045Attn: Diane Rennpferd
			DEC 1 1 2006
2.	Date Prepared:	October 18, 2006
3.	Name/Classificationof Device:	Adaptor, holder, syringeClass I, IQG, 21 CFR 890.5050Syringe, PistonClass II, FMF, 21 CFR 880.5860
	4. Trade Name ofProposed Device:	iSecure Syringe Cartridge Holder

Predicate Devices: 5.

Device Name	510(k) Number
Empty Sterile Carpuject® Cartridge	K820164
Syringe holder Accessory

Proposed Device Description: 6.

7. Statement of Intended Use:

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Summary of Technological Characteristics of New Device Compared to Predicate 8. Devices

The iSecure Syringe Cartridge Holder as described in this submission is substantially equivalent to the predicate Empty Sterile Carpuject Syringe Holder Accessory with respect to the following characteristics:

. Both devices are intended to be used with either empty or prefilled (not the subject of this submission) Carpuject cartridges
The technology and operating principles are the same for both devices .

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The plunger rod for both devices is attached to the end of the syringe cartridge to . actuate an injection.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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-like symbol with three overlapping, curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Diane Rennpferd Senior Associate, Global Regulatory Affairs Devices Hospira, Incorporated 275 North Field Drive Dept. 389, Bldg. H2 Lake forest, Illinois 60045

DEC 1 1 2006

Re: K063180

Trade/Device Name: iSecure Syringe Cartridge Holder Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, IQG Dated: November 20, 2006 Received: November 21, 2006

Dear Ms. Rennpferd:

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.

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Page 2 - Ms. Rennpferd

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,

Sudra y Michael MD.

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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name: iSecure Syringe Cartridge Holder

Indications for Use:

The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 890.5050 Daily activity assist device.

(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.