GRADUATED ADAPTER WITH CLAVE

K080007 · Icu Medical, Inc. · EZD · May 13, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080007
• Device Name: GRADUATED ADAPTER WITH CLAVE
• Applicant: Icu Medical, Inc.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

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 Story

Graduated Adapter with Clave is a sterile, single-use accessory for urinary catheters. Device consists of a Clave needless connector solvent-bonded to a graduated adapter. Physician manually inserts graduated adapter into open end of urinary catheter; connects syringe or ISO 594-1/-2 compliant luer to Clave. Enables infusion or withdrawal of fluids from bladder. Clave connector provides closed system; withstands back pressures up to 45 psi to prevent leakage when syringe/luer is disconnected. Used in clinical settings by physicians to simplify patient care and facilitate bladder procedures. Benefits include ease of use for caregivers and secure fluid management.

Clinical Evidence

Bench testing only. Device performance validated against international standards for connecting components. Biocompatibility confirmed per ISO 10993-1. Sterilization validated per ISO 11137-1 to achieve a Sterility Assurance Level (SAL) of 10^-6. No clinical data presented.

Technological Characteristics

Materials: ABS or Cyrex (spike body), LSR (stepped silicone plug), Polyester (body), Polycarbonate (graduated adapter). Connectivity: ISO 594-1 & -2 compliant luer. Sterilization: Gamma or E-Beam radiation. Form factor: Slip-fit graduated adapter with integrated needless connector. Mechanical principle: Manual fluid path activation via luer connection; silicone plug seal.

Indications for Use

Indicated for patients requiring urinary catheterization; facilitates fluid transfer into or out of the bladder. For use as an accessory to a urinary catheter. Single procedure use only; connection to catheter not to exceed 30 days.

Regulatory Classification

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).

Predicate Devices

• Clave Connector (K915571)
• Clave Connector (K970855)
• Clave Needless Connector (K941190)
• Primary IV Set (K964435)
• Y-Clave Connector with Integrated Check Valve (K042182)
• Urethral Catheter and Urine Catheter Kit (K041464)

Submission Summary (Full Text)

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# 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:

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.

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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:

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.

| Component: | ICU Medical<br>Graduated Adapt.<br>with Clave | ICU Medical Clave<br>Needless Connector | Urine Catheter Kit by<br>Busse Hospital<br>Disposables |
|--------------------------|-----------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Spike Body: | ABS or Cyrex | ABS or Cyrex | N/A |
| Stepped Silicone<br>Plug | LSR – Liquid Silicone<br>Rubber | LSR – Liquid Silicone<br>Rubber | N/A |
| Body: | Polyester | Polyester | N/A |
| Graduated<br>Adapter | Polycarbonate | N/A | Polypropylene connectors,<br>PVC catheters, Polycarbonate<br>specimen containers |
| Sterilization<br>method: | Gamma / E-Beam | Gamma / E-Beam | Gamma or ETO |
| Other component: | N/A | Various: polycarbonate,<br>PVC, polypropylene, ABS,<br>Cyrex & more | PVC catheter, etc. |
| 510(k) Approval | This submission | K915571; K970855;<br>K941190; K964435;<br>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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. There are three stars below the word "Centennial". The text around the circle is difficult to read.

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 [phone] or [phone] 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:

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.

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