MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

K022391 · Organ Recovery Systems, Inc. · KDN · Oct 21, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022391
• Device Name: MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
• Applicant: Organ Recovery Systems, Inc.
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Oct 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Intended Use

KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

Device Story

KPS-1 is a sterile, non-pyrogenic, non-toxic extracellular solution used for flushing and hypothermic machine perfusion of explanted kidneys. The solution is cooled to 4°C–8°C and used within a compatible perfusion machine to maintain hypothermic conditions during storage and transport. It supports a mean perfusion time of approximately 29 hours. The solution is intended for use by clinical professionals involved in organ procurement and transplantation. By maintaining the kidney in a hypothermic, perfused state, the device preserves organ viability for eventual transplantation into a recipient.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and formulation consistency with the predicate device.

Technological Characteristics

Extracellular solution; approximate osmolarity 300mOsM; sodium 100mEq/L; potassium 25mEq/L; pH ~7.4 at room temperature. Sterile, non-pyrogenic, non-toxic. Requires external perfusion machine capable of maintaining 4°C–8°C. Shelf-life 6 months, verified by accelerated aging.

Indications for Use

Indicated for in-vitro flushing and temporary continuous hypothermic machine perfusion of explanted kidneys during donor removal, storage, and transport prior to transplantation.

Regulatory Classification

Identification

An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

Predicate Devices

• KPS-17M, Kidney Perfusion Solution (K013575)

Submission Summary (Full Text)

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## 022391 1 of 3

# OCT 21 2002

#### 510(k) SUMMARY

### Organ Recovery Systems, Inc. KPS-1, Kidney Perfusion Solution

### 1. SUBMITTER INFORMATION

- A. Organ Recovery Systems, Inc., 701 E. Bay St., Suite 433 MSC 1119 Port City Center Charleston, SC 29403
Federal Identification Number: 36-4256620

- B. Official Correspondent:
Stanley J. Harris, Director, Regulatory and Clinical Affairs

Phone: [phone] ex. 29 [phone] Fax:

### 2. DEVICE IDENTIFICATION

| A. Classification Name: | Isolated kidney perfusion and transport system and<br>accessories (21 CFR 876.5880) |
|-------------------------|-------------------------------------------------------------------------------------|
| B. Classification: | Class II, Gastroenterology/Urology Panel |
| C. Common/Usual Name: | Cold Storage Solution |
| D. Proprietary Name: | KPS-1, Kidney Perfusion Solution |

#### 3. PREDICATE DEVICE

KPS-17M, Kidney Perfusion Solution (K013575) (University of Wisconsin Machine Perfusion Solution Formulation)

Indications for Use: KPS-1, Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

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Device Description: KPS-17M, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

#### 4. DESCRIPTION OF DEVICE

KPS-17M, Kidney Perfusion Solution (University of Wisconsin Machine Perfusion Solution Formulation)

Indications for Use: KPS-1, Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary continuous bypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

Device Description: KPS-1™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300m()sM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

KPS-1™ should be cooled to about 5°C (4°C to 8°C) prior to use and should be used in a perfusion machine that is capable of maintaining temperature within the above specified range.

It is recommended that the KPS-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.

KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.

KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.

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#### SUBSTANTIAL EQUIVALENCE

- A. Indications for Use: The indications for use remain unchanged for the modifications requested within this submission.
- B. Technological Characteristics: Unchanged from Original Submission.

## 5. CONCLUSION

KPS-1™, The Kidney Perfusion Solution has the same intended use as the original submission (K013575) and the data presented in this submission demonstrates that the device modifications to KPS-1™, The Kidney Perfusion Solution is substantially equivalent to original submission (K013575).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 1 2002

Mr. Stanley J. Harris

Director, Regulatory and Clinical Affairs Organ Recovery Systems, Inc. 701 East Bay Street, Suite 433 Port City Center, MSC 1119 CHARLESTON SC 29403

Re: K022391

Trade/Device Name: KPS-1 ™ The Kidney Perfusion Solution . Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: 78 KDN Dated: September 23, 2002 Received: September 24, 2002

Dear Mr. Harris:

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 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.

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.

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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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KPS-1™, The Kidney Perfusion Solution Special 510(k): Device Modifications July 16, 2002 Page 8 of 86

#### 5. INDICATIONS FOR USE STATEMENT

.

Device Name: KPS-1™ The Kidney Perfusion Solution

#### Indications for Use:

KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

**Prescription Use**
**(Per 21 CFR 801.109)**

Daniel A. Symm
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices 510(k) Number