(88 days)
Not Found
No
The 510(k) summary describes a chemical solution for organ preservation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a solution used for preserving organs (kidneys) outside the body, not directly for treating a patient's disease or condition within the body. Its purpose is for organ preservation prior to transplantation, not therapy for the recipient.
No
The device is a solution used for flushing and preserving kidneys for transplantation, not for diagnosing medical conditions.
No
The device description clearly states it is a "solution," which is a physical substance, not software. The intended use also describes a process involving flushing and perfusion, which requires physical interaction with the organ.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys". "In-vitro" means "in glass" or "outside of the living organism". This is a key characteristic of IVDs.
- Device Description: The description reinforces the "in-vitro" nature by describing a "solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys". Explanted kidneys are outside of the body.
- Lack of In-Vivo Use: There is no mention of this solution being used within a living patient for diagnosis or treatment. Its purpose is solely for the preservation and preparation of an organ before transplantation.
While the device is used in the context of organ transplantation, its function is to maintain the viability of the organ outside of the body, which falls under the definition of an in-vitro process.
N/A
Intended Use / Indications for Use
KPS-I™, The 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.
Product codes (comma separated list FDA assigned to the subject device)
78 KDN
Device Description
KPS-I™, 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 votassium concentration of 25mEg/1, 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-I™ should be cooled to about 5 ℃ (4℃ to 8 ℃) 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-I™ be stored between 2 ℃ and 8 ℃. The solution should not be frozen or exposed to excessive heat.
KPS-I™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/- 8 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
KPS-ITM, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 6 of 10
K013575
Page 1 of 3
JAN 2 5 2002
510(k) SUMMARY
Organ Recovery Systems, Inc. KPS-I™ The 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: (843) 853-6756 ex. 29 Fax: (843) 722-6657
2. DEVICE IDENTIFICATION
| A. Classification Name: | Isolated kidney perfusion and transport system and
accessories (21 CFR 876.5880) |
|-------------------------|-------------------------------------------------------------------------------------|
| B. Classification: | Class II, Gastroenterology/Urology Panel |
| C. Common/Usual Name: | Cold Storage Solution |
| D. Proprietary Name: | KPS-ITM, The Kidney Perfusion Solution |
3. PREDICATE DEVICE
Belzer MPS™ (UW Kidney Preservation Solution), Trans-Med Corporation (Elk River, MN), 510(k) Notification Number K972066
Indications for Use: Belzer MPSTM is the UW-gluconate perfusion solution indicated for flushing and continuous hypothermic machine perfusion of explanted donor kidneys.
1
KPS-17M, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 7 of 10
K013575
Page 2 of 3
Device Description: Belzer MPS™ is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro 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 of Belzer MPSTM is thus consistent with that of an extracellular solution.
4. DESCRIPTION OF DEVICE
KPS-I™, The Kidney Perfusion Solution (University of Wisconsin Machine Perfusion Solution Formulation)
Indications for Use: KPS-I™, The 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.
Device Description: KPS-I™, 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 votassium concentration of 25mEg/1, 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-I™ should be cooled to about 5 ℃ (4℃ to 8 ℃) 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-I™ be stored between 2 ℃ and 8 ℃. The solution should not be frozen or exposed to excessive heat.
KPS-I™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/- 8 hours.
5. SUBSTANTIAL EQUIVALENCE
- A. Indications for Use: KPS-I™, The Kidney Perfusion Solution are identical in intended use to Belzer MPSTM
- B. Technological Characteristics: KPS-I™, The Kidney Perfusion Solution and Belzer MPS™ are both clear, sterile, non-pyrogenic solutions containing various components in the categories of ions, pH buffers, impermeants, colloids and pharmacologics intended to reduce metabolism and preserve
2
KPS-I'M, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 8 of 10
K013575
Page 3 of 3
physiological conditions of explanted organs during cold storage. They have the same pH value, 7.4 +/-. 15 and an osmolarity of 300 +/-15mOsm/L. . The solutions are the same in that both the KPS-I™, The Kidney Perfusion Solution and Belzer MPS™ contains a sodium/potassium ratio (high/low) characteristic of an extracellular solution enables it to function well for hypothermic machine perfusion.
6. Conclusion
KPS-I™, The Kidney Perfusion Solution has the same intended use as Belzer MPS. The solution formulation is identical and packaging system that is employed is identical to the predicate device. Data contained in the 510(k) demonstrates that KPS-IM, The Kidney Perfusion Solution is substantially equivalent to Belzer MPS.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Mr. Stan Harris Director, Regulatory and Clinical Affairs Organ Recovery Systems Charleston Research Center 701 East Bay Street, Suite 433 MSC 1119, Port City Center CHARLESTON SC 29403
Re: K013575 Trade/Device Name: KPS-ITM, 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: October 22, 2001 Received: October 29, 2001
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. Iisting 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.
4
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K013575
Device Name: KPS-I™ The Kidney Perfusion Solution
Indications For Use:
KPS-I™ 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seppan
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)