The Spiros, a CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

Device Description

The Spiros is a closed connector which is compatible with and used to access, standard female luers and known needlefree connectors. The Spiros is a normally closed design which will prevent the leakage of fluid or ingress of air when in the inactivated state. When activated the luer is an open two-way conduit for fluid flow. The Spiros will be an accessory to an IV administration device including tubing sets and syringes, such that an integral female luer is used to connect to such devices.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested.

The document is a Special 510(k) Summary for the Spiros™ Closed Male Luer, and it focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria as typically found in medical device approvals based on clinical trials or extensive engineering verification.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

Acceptance Criteria and Device Performance:

The document states: "The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria." However, it does not list what those specific acceptance criteria are, nor does it report specific device performance metrics against those criteria. It only makes a general statement of compliance.

Missing Information (Not found in the provided text):

A table of acceptance criteria and reported device performance.
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth.
Qualifications of experts.
Adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
Effect size of human reader improvement with AI vs. without AI assistance.
If a standalone (algorithm only) performance study was done.
Type of ground truth used (pathology, outcomes data, expert consensus, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Information Extracted from the Text:

Since the detailed information for the requested table and study details is not present, I will summarize the general statements made in the document regarding testing and equivalence.

Summary of Device Evaluation (Based on provided text)

Device Name: Spiros™ Closed Male Luer

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document	"passed all acceptance criteria"
Functional Claims	"meets the functional claims"
Intended Use	"meets the intended use as described in the product labeling"

Note: The document makes general statements about passing acceptance criteria and meeting claims but does not provide specific quantitative or qualitative criteria or corresponding performance data.

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

Sample Size: Not specified.
Data Provenance: Not specified. (The document mentions testing "post sterilization," implying laboratory or engineering testing, not clinical data.)

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

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified.
This type of evaluation is not relevant as this is a device for fluid administration, not one requiring expert human interpretation of data (like medical images).

4. Adjudication method for the test set:

Not applicable/Not specified.

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:

No. This type of study is not relevant for this device. The Spiros™ is a physical medical device (closed male luer) for intravenous fluid administration, not an AI-powered diagnostic or assistive technology that would involve human readers or AI algorithms for interpretation.

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

No. Not applicable as this is a physical device, not an algorithm.

7. The type of ground truth used:

The concept of "ground truth" as typically applied to diagnostic or AI devices is not explicitly detailed here. The evaluation of this device would involve engineering and performance testing against established physical and functional standards (e.g., fluid leakage tests, pressure resistance, sterility, biocompatibility), rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

Not applicable/Not specified. (This device does not involve a "training set" in the context of machine learning or AI.)

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

Not applicable/Not specified.

Study that Proves the Device Meets the Acceptance Criteria:

The document states: "The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria."

Nature of the Study: Based on the context of a 510(k) for a physical medical device (intravascular administration set accessory), the "study" referred to would be a series of verification and validation (V&V) tests, including:
- Performance testing: To ensure the device functions as intended (e.g., preventing leakage, allowing fluid flow when activated, resistance to pressure).
- Biocompatibility testing: To ensure materials are safe for patient contact.
- Sterilization validation: To confirm the device can be consistently sterilized.
- Shelf-life testing: To ensure stability over time.
- Material compatibility testing: Especially given the change in polycarbonate vendor and the addition of an O-ring.
Evidence of Meeting Criteria: The document asserts that the device "passed all acceptance criteria" and "meets the functional claims and intended use." The basis for this claim is the "testing post sterilization." This aligns with the requirements for demonstrating substantial equivalence for a Class II device.
Specifics Missing: The document does not provide details of which specific tests were conducted, what the passing thresholds were, or what the actual results recorded were for each test. This level of detail is typically contained in the full 510(k) submission, not necessarily in the summary provided for the public. The focus of the provided summary is to highlight substantial equivalence to an existing predicate device, primarily through comparing features and stating that performance testing confirmed safety and effectiveness.

Summary

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ICU Medical, Inc. - CML TM Special 510(k) / February 2006

Special 510(k) Summary
------------------------

Name of Submitter: ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

Manufacturer and Establishment Registration Number:

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

Proprietary or Trade Name of Proposed Device: Spiros™

Common Name: Closed Male Luer

Device Classification: Class II

ProCode: FPA

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for set, administration, intravascular. Set, administration, intravascular are regulated within 21 CFR 880,5440.
Intended Use / Indications for Use: The Spiros, a CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

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ICU Medical, Inc. - CML TM Special 510(k) / February 2006

Proposed Device Description: The Spiros is a closed connector which is compatible with and used to access, standard female luers and known needlefree connectors. The Spiros is a normally closed design which will prevent the leakage of fluid or ingress of air when in the inactivated state. When activated the luer is an open two-way conduit for fluid flow. The Spiros will be an accessory to an IV administration device including tubing sets and syringes, such that an integral female luer is used to connect to such devices.

Summary of Substantial Equivalence:

Similarities:

1. The predicate and subject devices have the same intended use.
1. The predicate and subject devices have the same indications for use.
1. The predicate and subject devices contain the components made from the same materials with the one exception noted below.

Differences:

1. The subject device will use a Polycarbonate material from a different vendor than the predicate device. This material is used on another legally marketed device by ICU Medical, Inc.
1. The subject device contains two internal o-ring seals while the predicate device contains one internal o-ring seal
1. The subject device contains a female luer ultrasonically welded to it; the predicate device contains a female luer that is solvent bonded to a short piece of tubing which is in turn solvent bonded to the device.

Statement of Safety and Effectiveness:

The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria. The Spiros™ closed male luer 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 device described in this document.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 2 0 2007

Re: K070532

Trade/Device Name: SpirosTM Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 23, 2007 Received: February 26, 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 (OS) 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

Enclosure

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Indications for Use

k 000532 1

510(k) Number (if known):

Device Name: Spiros™

Indications for Use: The Spiros™ is a single use, sterile, non-pyrogenic, swab-able, bidirectional valve device intended for use as an accessory to Intravascular Administration Set. The Spiros™ provides access of the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

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)

Page 1 of 1

Rild C. Chaye 3/19/07 for Aow

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1 1 15 15 . 3 . .

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.