The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

Device Description

The Genie™ is intended for use as an accessory to an I.V. set. The Genie™ is used to adapt a standard medication vial for needle free access and to maintain the sterile system. In addition, the Genie™ automatically equalizes vial pressure as fluids are withdrawn and therefore reduces the risk for health-care workers for exposure to potentially hazardous drug aerosols, spills or needle sticks that can occur during the preparation, administration and dispensing process.

AI/ML Overview

The provided text describes a 510(k) submission for the Genie™ vial access device, which is an accessory to a syringe. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be fully addressed from the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

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

The document states: "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." However, the specific acceptance criteria (e.g., maximum leakage, pressure equalization rate, sterility maintenance duration) and the quantitative results (reported device performance) are not provided in this summary.

Acceptance Criteria	Reported Device Performance
(Not specified in the document)	"passed all acceptance criteria"
(Not specified in the document)	"meets the functional claims and intended use"

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 provided in the document. The text only mentions that the device "has been tested," but does not detail the testing methodology, sample size, or the nature of the data (e.g., if it was from real-world usage or laboratory testing).

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 provided as the document describes a device submission based on substantial equivalence and testing, not a study involving expert assessment or ground truth establishment in a clinical context.

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

This information is not provided.

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 to this device. The Genie™ is a physical accessory designed to improve user safety by reducing exposure to hazards, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device as it is a physical medical accessory, not an algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies does not directly apply here. Instead, the device's performance would be judged against functional and safety standards (e.g., sterility, pressure equalization, leakage) through laboratory testing. The document implies that the "ground truth" for demonstrating safety and effectiveness was based on passing these established acceptance criteria.

8. The sample size for the training set

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

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

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the "study" demonstrating the device meets acceptance criteria appears to be a series of "post sterilization" tests to ensure functionality, safety, and effectiveness.

Study Type: The document describes the process as "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." This implies a laboratory-based testing regimen and engineering verification/validation rather than a human-centered clinical trial or an AI performance study.
Purpose: To demonstrate that the Genie™ vial access device functions as intended (providing sterile access, equalizing pressure, reducing exposure to hazards) and is safe, thereby establishing substantial equivalence to predicate devices (K001368, specifically mentioned for its pressure equalization mechanism).
Key Finding: The device "passed all acceptance criteria" and "meets the functional claims and intended use."

The document focuses on explaining that the device is substantially equivalent to existing predicate devices due to shared intended use, indications for use, and materials, with the main difference being the internal versus external balloon for pressure equalization. The overall claim for safety and effectiveness is tied to passing these unspecified acceptance criteria.

Summary

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K070633 page 1 of 2

ICU Medical, Inc. - Genie Traditional 510(k) / February 2006

5. Traditional 510(k) Summary

Name of Submitter:	ICU Medical, Incorporated4455 Atherton DriveSalt Lake City, Utah 84123	JUN - 5 2007
--------------------	--------------------------------------------------------------------------------	--------------

Manufacturer and Establishment Registration Number:

Manufacturer:	Sterilization Site:
ICU Medical (Utah), Inc	ICU Medical de Mexico, S.A. de C.V.
4455 Atherton Drive	Avenida Cuarzo #250
Salt Lake City, Utah 84123	Colonia Rancho Santa clara
	El Valle de Maneadero
Site Registration Number: 1713468	Ensenada, B.Cfa., MEXICO 22790
	Site Registration Number: 9617594
-- OR --
ICU Medical de Mexico, S.A. de C.V.	Beam-One LLC
Avenida Cuarzo #250	9020 Activity Rd., suite D
Colonia Rancho Santa clara	San Diego, California 92126
El Valle de Maneadero
Ensenada, B.Cfa., MEXICO 22790	Site Registration Number: 2030598

Site Registration Number: 9617594

Proprietary or Trade Name of Proposed Device: Genie™

Common Name: Vial Access Device

Device Classification: Class II

Product Code: FMF, MEG

Performance Standards:

There is a performance standard for this Classification Product Code FMF (Primary) and MEG (Secondary) under Section 514 of the Food, Drug and Cosmetic Act for Syringe, Piston, Needleless. This device is an accessory to a Piston Syringe, and is regulated within 21 CFR 880.5860.

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Intended Use / Indications for Use:

Proposed Device Description:

Summary of Substantial Equivalence:

Similarities:

1. The predicate and subject devices have the same or similar intended use.
1. The predicate and subject devices have the same or similar indications for use.
1. The predicate and subject devices contain the components made from materials tested and qualified per ISO 10993-1:2003.

Differences:

1. The subject device will use an internal balloon for pressure equalization, while the predicate device (K001368) uses an external balloon or a filtered vent.

Statement of Safety and Effectiveness:

The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria. The Genie™ vial access device meets the functional claims and intended use as described in the product labeling and is safe and effective in terms of substantial equivalence as the predicate devices described in this document.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design, with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and the country it represents.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Martin Maier Senior Quality Assurance ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

JUN -5 2007

Re: K070633

Trade/Device Name: Genie™ Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 6, 2007 Received: March 7, 2007

Dear Mr. Maier:

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 - Mr. Maier

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,

Chris Liu, 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

Enclosure

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Indications for Use

510(k) Number (if known): __K070633

Device Name: Genie™M

Indications for Use:

Prescription Use _ X (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)

Anton Doma

ision Sign-Off) Civision of Anesthesiology, General Hospital, In schon Control, Dental Devices

510(k) Number: K092633

Page 1 of 1

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).