ICU Medical Graduated Adapter with Clave® is indicated as an accessory to a urinary catheter which facilitates the transfer of fluids into or out of the bladder via connection to the graduated adapter. This device for single procedure use only. Connection to catheter not to exceed 30 days.

Device Description

The Clave with Graduated Adapter is a device that allows the Urologist a device that can "slip-fit" on a urology catheter. This is then used to infuse fluids into the bladder for procedures as the physician determines. The Clave can connect to a threaded device or any ISO 594-1 & -2 compliant luer device. When the Clave is activated, fluid may then pass through the graduated adapter. When the syringe or luer is disconnected, the Clave can withstand back pressures as much as 45 psi and thereby preclude fluid leakage coming from the bladder via the catheter and attachment.

The submitted device consists of a Clave which has a spike, stepped silicone plug and body that is then solvent-bonded to a graduated adapter using cyclohexanone, dichloride or validated equivalent.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Graduated Adapter with Clave®" by ICU Medical, Inc. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through standalone performance or comparative effectiveness studies.

Here's an analysis based on the provided text, addressing your questions where information is available:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance results. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the new device shares similar technological characteristics and is as safe and effective as a legally marketed device that does not require premarket approval.

The primary "acceptance criteria" appear to be:

Substantial Equivalence: The device must be deemed substantially equivalent to predicate devices in terms of materials, performance, and operational features.
Safety and Effectiveness: The device must be safe and effective for its intended use.
Compliance with Standards: The device complies with published international standards for connecting components, ISO 10993-1 for biocompatible materials, and ISO 11137-1 for sterilization by radiation.
Sterility Assurance Level (SAL): The SAL has an established and validated history of meeting the 10⁻⁶ level.

The document reports the following as evidence of meeting these general 'criteria':

Characteristic / "Acceptance Criteria"	Reported Device Performance (or justification)
Technological Characteristics	* Spike Body: ABS or Cyrex (Same as predicate Clave)
	* Stepped Silicone Plug: LSR – Liquid Silicone Rubber (Same as predicate Clave)
	* Body: Polyester (Same as predicate Clave)
	* Graduated Adapter: Polycarbonate (New component, but similar to polypropylene connectors/polycarbonate specimen containers in Busse kit predicate)
	* Sterilization Method: Gamma / E-Beam (Same as predicate Clave, similar to predicate Busse which also uses Gamma or ETO)
	* Operational Characteristics: Manually inserting into catheter, connecting Clave to syringe/Luer to infuse/withdraw fluids. "The operational characteristics are equivalent" to predicate devices, allowing fluid transfer. The Clave can withstand back pressures of 45 psi, precluding fluid leakage.
Material Biocompatibility	Complies with ISO 10993-1 for biocompatible materials.
Sterilization	Complies with ISO 11137-1 for sterilization by radiation. SAL has an established and validated history of meeting the 10⁻⁶ level.
Substantial Equivalence	"The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and are safe and effective for their intended use." This is the ultimate conclusion based on the comparison of characteristics. The FDA's 510(k) clearance confirms this determination.
Safety and Performance	ICU Medical complies with published international standards to ensure commonality of connecting components. All standards complied with are listed in the CDRH Cover Sheet (which is not provided but implied to exist). The device is packaged to ensure conformity. "The Clave can withstand back pressures as much as 45 psi and thereby preclude fluid leakage coming from the bladder via the catheter and attachment." (This is a performance characteristic).

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

This document does not describe a clinical study with a "test set" in the sense of patient data. The evaluation is primarily based on bench testing, material characterization, and comparison to predicate devices. Therefore, there is no sample size of patients or data provenance related to human subjects from a test set.

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 is not applicable as there was no test set of human data requiring ground truth established by experts. The "ground truth" for this type of submission is typically adherence to engineering standards, material specifications, and functional bench test results. The experts involved would likely be engineers and quality control personnel within ICU Medical, along with FDA reviewers.

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

Not applicable. There was no test set requiring adjudication in this context.

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 mechanical connector/adapter accessory, not an AI-powered diagnostic or therapeutic tool. There are no "human readers" to improve with or without AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm. Bench tests would have been performed on the device in a "standalone" manner to confirm its physical properties and fluid handling capabilities, as indicated by the mention of "45 psi" back pressure resistance.

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

The "ground truth" for this 510(k) submission is primarily derived from:

Engineering Specifications and Standards: Compliance with ISO standards (10993-1, 11137-1) and internal design specifications.
Bench Test Results: Functional tests (e.g., pressure resistance, fluid flow) conducted on the device.
Material Characterization: Verification that the materials used (ABS, Cyrex, LSR, Polyester, Polycarbonate) meet their specified properties and are suitable for the intended use and biocompatibility.
Predicate Device Equivalence: The performance and safety profile of already legally marketed devices serve as a benchmark.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ICU Medical, Inc. The logo features a gray horse on the left side of the image. The text "ICU Medical, Inc." is in blue and is located to the right of the horse.

ICU MEDICAL INC. 4455 Atherton Drive

Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Mr. Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: May 06, 2008

Traditional 510(K) - Summary of Safety and Effectiveness for the:

Trade Name: Graduated Adapter with Clave® Common Name: Needless connector with graduated adapter Accessory to Urological Catheter 21 CFR 876.5130 (EZD) Classification Name:

Legally Marketed Predicate Devices for Substantial Equivalence:

*K915571 - Clave Connector - ICU Medical Inc.

- K970855 Clave Connector ICU Medical, Inc.
- K 941190 Clave Needless Connector ICU Medical, Inc.
*K964435 Primary IV Set ICU Medical, Inc.
*K042182 Y-Clave Connector with Integrated Check Valve ICU Medical, Inc.
*K041464 Urethral Catheter and Urine Catheter Kit Busse Hospital Disposables

Rationale for SE:

The Clave is a needless adapter that is used individually or in combination with other devices more than 6 million times annually around the world. The adaption of a graduated adapter is new to the clave, but accessories integrated with the Clave to make patient care easier for the caregiver is not new concept. As shown in K964435 and K941190, these submissions included adaptors for different purposes to use the Claye that fall outside the original intended use as defined in K915571. I.V. Sets and various componentry integrated the use of the Clave as requested by the physician and as needed for better patient care. ICU Medical is a custom kit manufacturer in the disposable infusion therapy market. The Graduated Adapter with Clave has been developed for the same purpose; to help make the caregiver's job easier and to simplify patient care by providing this presterilized device for those physicians that use them. The Urine Catheter Kit from Busse (K041464) is an example of how companies develop different kits for physicians for the care of patients.

Description of Submitted Device:

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The submitted device consists of a Clave which has a spike, stepped silicone plug and body that is then solvent-bonded to a graduated adapter using cyclohexanone, dichloride or validated equivalent.

Intended Uses of the ICU Medical Syringe:

Component:	ICU MedicalGraduated Adapt.with Clave	ICU Medical ClaveNeedless Connector	Urine Catheter Kit byBusse HospitalDisposables
Spike Body:	ABS or Cyrex	ABS or Cyrex	N/A
Stepped SiliconePlug	LSR – Liquid SiliconeRubber	LSR – Liquid SiliconeRubber	N/A
Body:	Polyester	Polyester	N/A
GraduatedAdapter	Polycarbonate	N/A	Polypropylene connectors,PVC catheters, Polycarbonatespecimen containers
Sterilizationmethod:	Gamma / E-Beam	Gamma / E-Beam	Gamma or ETO
Other component:	N/A	Various: polycarbonate,PVC, polypropylene, ABS,Cyrex & more	PVC catheter, etc.
510(k) Approval	This submission	K915571; K970855;K941190; K964435;K045182	K041464

Technological Characteristics and Substantial Equivalence Table:

The operational characteristics are equivalent: by manually inserting the graduated adapter into the open end of the catheter, then connecting the Clave to a syringe or an ISO 594-1; -2 compliant Luer to allow the physician to infuse or withdraw fluids.

Safety and Performance:

ICU Medical complies with published international standards to ensure the commonality of connecting components. All standards complied with are listed in the CDRH Cover Sheet. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting the 10° level. This single use Graduated Adapter with Clave are packaged to ensure conformity with ISO 10993-1 for biocompatible materials and ISO 11137-1 for sterilization by radiation.

Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and are safe and effective for their intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 13 2008

Mr. Tracy Best Sr. Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive SALT LAKE CITY UT 84123

Re: K080007

Trade/Device Name: Graduated Adapter with Claye® Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and KNY Dated: April 4, 2008 Received: April 7, 2008

Dear Mr. Best:

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 (Premarket Approval), 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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Protecting and Promoting Public Health

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Page 2

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 Aut or any Federal statutes and regulations administered by other Federal agencies. You must to 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 s set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed be on 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 logally marketed predicate device results in a classification for your device and thus, cormorts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a t one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device 2-eo-2, ing (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You portun 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080007

Device Name: Graduated Adapter with Clave®

Indications for Use:

Prescription Use XX (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)

Signature

on Sign-Off) (Divis Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.