The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution System may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.

Device Description

Clip'n'Ject Reconstitution System is a single use device intended to transfer, mix and inject lyophilized drugs contained in vials. The Clip'n'Ject Reconstitution System shown in Figure 1 is comprised of a sliding joint and connector and is compatible with a BD Readyfill or comparable syringe(s). The syringe and needle would be legally authorized through its own clearance or customer NDA and is not intended to be cleared as part of this premarket notification. The needle is attached to the syringe by means of a standard luer connection. The sliding joint is placed onto a portion of the syringe. The syringe with the sliding joint and needle is inserted into the connector. The user attaches the Clip'n'Ject Reconstitution System to a vial by inserting the vial into the connector. The system is then activated by pressing down on the syringe. This advances the needle into the vial through the vial stopper. The user then attaches the plunger rod to the syringe. The contents of the syringe are then transferred into the vial. Mixing of the syringe contents and vial contents then occurs. After this is complete, the mixture is then drawn back into the syringe. The syringe with needle attached is then removed from the connector and sliding joint. The syringe can then be used for administration. This system is disposable and for single use only.

AI/ML Overview

The provided text describes the "Clip'n'Ject Reconstitution System" and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving device performance against such criteria in the detail requested by the prompt.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract the information that is present concerning performance, testing, and regulatory compliance.

Here's a breakdown of what is available in the provided text:

Summary of Performance and Compliance Information from the Document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria table or quantitative performance data (e.g., sensitivity, specificity, accuracy, error rates) is provided for the Clip'n'Ject Reconstitution System itself. The document states "A six (6) point comparison of technological characteristics... The devices were found to be substantially equivalent," indicating a qualitative comparison rather than a quantitative performance study with thresholds.

The document does list compliance with recognized consensus standards:

ANSI/AAMI/ISO 11135-1995: Guideline for Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
AAMI TIR 10:2000: Process Development and Performance Qualification for Ethylene Oxide Sterilization - Microbiological Aspects
AAMI/ANSI/ISO: 10993-7:1995 ® 2001: Biological Evaluation of Medical Devices part 7: Ethylene Oxide Sterilization Residuals

However, these are standards for sterilization and biocompatibility, not for the functional performance (e.g., drug transfer efficiency, leak rates, mixing effectiveness) of the reconstitution system itself as would be presented in a performance study with defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No performance study directly evaluating the Clip'n'Ject system against specific acceptance criteria is detailed. The comparison was for "technological characteristics."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method 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
Not applicable. This device is a medical device for drug reconstitution, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described. The "Summary of Technological Characteristics" mentions a six-point comparison. For substantial equivalence, the "ground truth" implicitly refers to the characteristics and performance capabilities of the predicate devices.

8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.

In summary, the provided document is a regulatory submission for substantial equivalence (510(k)) and not a detailed clinical or performance study with defined acceptance criteria and results for the device's functional attributes. It focuses on comparing technological characteristics and compliance with general standards rather than specific performance metrics.

Summary

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AUG - 5 2004

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Summary of Safety and Effectiveness for the Clip'n'Ject Reconstitution System

Submitted by:

West Pharmaceutical Services, Inc. 101 Gordon Drive Lionville, PA 19341

Contact Person

Please direct all inquiries regarding this submission to our official correspondent:

David Weiser Supervisor, Regulatory Affairs, the Americas 101 Gordon Drive Lionville, PA 19341

Telephone No .: (610) 594-2931 Facsimile No: (610) 594-3016

Classification Name: Fluid Transfer Set per 21 CFR § 880.5440

Common/Usual Name: Reconstitution system, administration system including a sliding joint and vial adapter

Proprietary Name: Clip'n'Ject™ Reconstitution System (Clip'n'Ject)

Identification of a Legally Marketed Predicate Device

West's Clip'n'Ject Reconstitution System is substantially equivalent to:

Inter Vial that is legally marketed and distributed by Duoject Medical Systems Inc. pursuant to premarket notification K010703
Needle-Free Adapter that is legally marketed and distributed by Bioject, Inc. pursuant to pursuant to premarket notification K963012;
Mixiect that is legally marketed and distributed by Medimop Medical products Ltd. pursuant to premarket notification K963853.

Device Description

Clip'n'Ject Reconstitution System is a single use device intended to transfer, mix and inject Ivophilized drugs contained in vials. The Clip'n'Ject Reconstitution System shown in Figure 1 is comprised of a sliding joint and connector and is compatible with a BD Readyfill or comparable syringe(s). The syringe and needle would be legally authorized through its own clearance or customer NDA and is not intended to be cleared as part of this premarket notification. The needle is attached to the syringe by means of a standard luer connection. The sliding ioint is placed onto a portion of the syringe. The syringe with the sliding joint and needle is inserted into the connector.

-JUN-2-1 2004

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The user attaches the Clip'n'Ject Reconstitution System to a vial by inserting the vial into the connector. The system is then activated by pressing down on the syringe. This advances the needle into the vial through the vial stopper. The user then attaches the plunger rod to the syringe. The contents of the syringe are then transferred into the vial. Mixing of the syringe contents and vial contents then occurs. After this is complete, the mixture is then drawn back into the syringe. The syringe with needle attached is then removed from the connector and sliding joint. The svringe can then be used for administration. This system is disposable and for single use only.

1041109

2 8 3

Product Configurations

The Clip'n'Ject Reconstitution System is available in three sizes to accommodate vials with 13 mm and 20 mm tops. The 20 mm version has two possible body diameters: 20.75 mm and 23.75 mm. The device for a 13 mm top vial will accommodate a 1 cc syringe: the device for the 20 mm top vial will accommodate a 3 cc syringe. Each size Clip'n'Ject Reconstitution System will be packaged with a customer specified diluent (e.g. Sterile water for injection (WFI). The matrix of configurations are shown in Table 1.

Vial CapDiameter	1 CCSyringe	3 CCSyringe
Clip'n'Ject - 13 mm	✓
Clip'n'Ject - 20 mm*		✓
Clip'n'Ject - 23.75 mm†		✓

:A Canadaa produktion and the provinsion of the provinsion of the first of the first of the first of the first of the first of the first of the first of the first of the first of the		1์41 Mar 1SISChildren

*To fit a vial with a 20 mm vial top diameter and a 20.75(nominal) vial body diameter +To fit a vial with a 20 mm vial top diameter and a 23.75(nominal) vial body diameter

Table 1 shows the current configurations available. Other combinations are possible without changing the design parameters for the system. These would include a connector that would attach a 3 cc syringe to a 13 mm vial top and a connector that would attach a 1 cc syringe to a 20 mm vial top

Intended Use

The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution system may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.

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Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The first line reads "Kriist" and the second line reads "3 - 3". The text appears to be written with a dark pen or marker, and the handwriting is somewhat stylized.

Summary of Technological Characteristics

A six (6) point comparison of technological characteristics of the West Pharmaceutical Services' Clip'n'Ject Reconstitution System and the predicate devices was performed. The devices were found to be substantially equivalent. The areas of comparison are: Intended use, sterilization method, packaging, vial size compatibility, piercing mechanism and housing material.

Summary of Performance Data

West Pharmaceutical Services' Clip'n'Ject Reconstitution System complies with the requirements of the following FDA Recognized Consensus Standards:

ANSI/AAMI/ISO 11135-1995, Guideline for Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
AAMI TIR 10:2000, Process Development and Performance Qualification for Ethylene Oxide Sterilization - Microbiological Aspects
AAMI/ANSI/ISO: 10993-7:1995 ® 2001, Biological Evaluation of Medical Devices part 7: Ethylene Oxide Sterilization Residuals

The West Clip'n'Ject Reconstitution System is substantially equivalent to:

Inter Vial that is legally marketed and distributed by Duoject Medical Systems Inc. (K010703);
Needle-Free Adapter that is leqally marketed and distributed by Bioject. Inc. (K963012):
Mixject that is legally marketed and distributed by Medimop Medical Products A Ltd. (K963583)

Request for Confidentiality

The information contained both in the body of this submission and marked as such is considered to be confidential within the meaning as set forth in 21 CFR Part 20.

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Image /page/3/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 an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Mr. David J. Weiser Supervisor, Regulatory Affairs, The Americas West Pharmaceutical Services, Incorporated Pharmaceutical Systems Division 101 Gordon Drive Lionville, Pennsylvania 19341

Re: K041691

Trade/Device Name: Clip'n' Ject Reconstitution System Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 21, 2004 Received: June 22, 2004

Dear Mr. Weiser:

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 reciclications for use stated in the enclosure) to legally marketed predicate devices marketed in murcations for ass battle to May 28, 1976, the enactment date of the Medical Device mersule oommerce press that have been reclassified in accordance with the provisions of Amondinone, of to active 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 Nr), it hay of bagges in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. For roublish further announcements concerning your device in the Ecderal Register.

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Page 2 - Mr. Weiser

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be authour ande a determination that your device complies with other requirements mean that 1 Dr man may Federal statutes and regulations administered by other Federal agencies. or the rece of any I each an the Act's requirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ibring (21 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form nrode it 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 premits themember. 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qurs

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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Kaulal
1 of 1

Indications for Use

510(k) Number (if known): _K041691

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent The Clip it Ject Reconstitution Oystom to a singled and the lyophilized drug, and Into a vial containing a lyophilized drug, mix the digin' lect Reconstitution
transfer the reconstituted drug into a standard syringe. The Clip'n lectingly transfer the reconismated drug into a started, and other practitioners who routinely System may be used by physiolane, harost, and other individuals authorized by their physician to administer injections of prescribed medication.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Anthony D. ms

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

510(k) Number: K441691

Page 1 of __ 1___

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.