(84 days)
Not Found
No
The 510(k) summary describes a chemical solution for organ preservation and storage, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No.
The device is a solution used for flushing and cold storage of organs for transplantation, not for treating a disease or condition in a living patient.
No
Explanation:
The device, CoStorSol® plus G, is an organ preservation solution used for flushing and cold storage of organs during transplantation. Its intended use and description do not mention any diagnostic capabilities, such as identifying, detecting, or measuring a medical condition or disease.
No
The device is a sterile, non-pyrogenic solution packaged in bags, which is a physical product, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the flushing and cold storage of organs (liver, kidney, pancreas) for transplantation. This is a process performed on the organ itself outside of the body, not on a sample of bodily fluid or tissue to diagnose a condition in a patient.
- Device Description: The description details a solution used for preserving organs. It's a chemical solution, not a test or assay designed to detect or measure substances in a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or kits for testing
The device is clearly intended for the preservation and handling of organs for transplantation, which falls under the category of medical devices used in surgical procedures and organ transplantation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ 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)
KDN
Device Description
Preservation Solutions, Inc. manufacturers CoStorSol® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds.
CoStorSol® plus G is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver, kidney, and pancreas organs
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Preservation Solutions, Inc. % Neil Burris Principal Consultant Neil Burris and Associates 4250 Grove Street Denver, CO 80211
Re: K151728
Trade/Device Name: CoStorSol® plus G Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories. Regulatory Class: II Product Code: KDN Dated: June 24, 2015 Received: June 26, 2015
Dear Neil Burris,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151728
Device Name CoStorSol plus G
Indications for Use (Describe)
CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
SUBMITTER INFORMATION
- A. Company Name: Preservation Solutions Inc.
- B. Company Address: 1099 Proctor Drive Elkhorn, Wisconsin 53121
- C. Company Phone: 262 723 6715
- D. Company Facsimile: 262 723 4013
- E. Contact Person: William Wagner Quality Assurance Director
DEVICE IDENTIFICATION
- A. Device Trade Name: CoStorSol® plus G
- B. Device Common Name: Organ Storage Solution
- C. Classification Name: Isolated kidney perfusion and transport system and accessories
- D. Class II (21 CRF 876.5880)
- E. Device Code: KDN
IDENTIFICATION OF PREDICATE DEVICES
CoStorSol® cold storage solution cleared to market under:
Premarket Notifications K091245, K083453, and K073693.
is an exact predicate to the proposed device CoStorSol® plus G.
DEVICE DESCRIPTION
Preservation Solutions, Inc. manufacturers CoStorSol® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds.
CoStorSol® plus G is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, to which 0.922 g of
4
sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.
INDICATIONS FOR USE
INTENDED USE
CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
COMPARISON TO PREDICATE DEVICES
CoStorSol® solution received substantial equivalence determinations after submissions filed under premarket notification (510(k)) numbers K091245, K083453, and K073693. The modified device, CoStorSol® plus G, is exactly the same as the predicate device, except that the new device will include a single vial of sterile glutathione powder (0.922 g). The glutathione is included as a convenience should the attending physicians, and/or transplant team, choose to use it as an optional additive to 1 Liter of CoStorSol® at the time of use. The Instructions for Use of CoStorSol® have always included statements advising the optional addition of 0.922 g of glutathione when deemed necessary due to the exact circumstances of the transplant case. Including a vial of glutathione in a package of CoStorSol® plus G thus represents no change to either the intended use or the specific methods of use for the device.
Substantial Equivalence Comparison Table for CoStorSol® plus G vs. CoStorSol®
| Device
Attribute | CoStorSol® plus G
(Proposed Device) | CoStorSol® K091245
(Predicate Device) | Equivalent? |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | •CoStorSol® plus G is intended for the
flushing and cold storage of liver, kidney,
and pancreas organs at the time of organ
removal from the donor in preparation for
storage, transportation and eventual
transplantation into a recipient. | CoStorSol® is intended for the flushing
and cold storage of kidney, liver and
pancreas organs at the time of organ
removal from the donor in preparation
for storage, transportation and eventual
transplantation into a recipient. | Identical |
| Preparation for
Use | Chill to 2° to 6° C without freezing;
Required addition to 1L of CoStorSol®:
Penicillin G-200,000 units, Insulin-40
Units, Dexamethasone-16mg;
Optional addition to 1L CoStorSol®:
glutathione 0.922g | Chill to 2° to 6° C without freezing;
Required addition to 1L of CoStorSol®:
Penicillin G-200,000 units, Insulin-40
Units, Dexamethasone-16mg;
Optional addition to 1L CoStorSol®:
glutathione 0.922g | Identical |
| Device
Attribute | CoStorSol® plus G
(Proposed Device) | CoStorSol® K091245
(Predicate Device) | Equivalent? |
| Chemical
Composition | A synthetic medium of defined organic,
and inorganic, soluble chemical
compounds with specified purity.
pH = 7.4 nominal
osmolality $\approx$ 320 mOsM | A synthetic medium of defined organic,
and inorganic, soluble chemical
compounds with specified purity.
pH = 7.4 nominal
osmolality $\approx$ 320 mOsM | Identical |
| Packaging -
How Supplied | Filter sterilized using 0.1μm membrane(s)
and aseptically filled into biocompatible, 1
liter flexible solution bags made of
laminated plastic with an ethylene-vinyl-
acetate (EVA) layer contacting the
solution. The bags have integrated
delivery set ports, and are packaged with
a single 10mL polyethylene terephthalate
(PETG) vial holding 0.922 g sterile non-
pyrogenic glutathione.
CoStorSol® is non-pyrogenic. Shelf
packs contain 6, 1-liter bags and 6 vials
of glutathione powder | Filter sterilized using 0.1μm membrane(s)
and aseptically filled into biocompatible,
1 liter flexible solution bags made of
laminated plastic with an ethylene-vinyl-
acetate (EVA) layer contacting the
solution. The bags have integrated
delivery set ports. CoStorSol® is non-
pyrogenic. Shelf packs contain 10, 1-
liter bags. | Substantially
Equivalent -
Sterile
glutathione, an
optional additive
to both the
subject device
and predicate,
is provided with
1L units of
CoStorSol®. |
| Sterility | Sterility Assured via 0.1 μm membrane
filtration | Sterility Assured via 0.1 μm membrane
filtration | Identical |
| Storage
Temperature
and Shelf Life | Indoors with temperature controlled at 2°-
25°C, without freezing;
1year (12 month) shelf life | Indoors with temperature controlled at
2°-25°C, without freezing;
1 year (12 month) shelf life | Identical |
| Actions and
Functions | Use cold solution to flush organ
immediately before and/or after removal
to clear blood from the vasculature. Store
organs cold in aliquot of the same solution
to maintain histological viability by
depressing metabolism. | Use cold solution to flush organ
immediately before and/or after removal
to clear blood from the vasculature.
Store organs cold in aliquot of the same
solution to maintain histological viability
by depressing metabolism. | Identical |
| Particulate
Matter and
Biocompatibility | Particle Counts less than limits for Large
Volume Injections per USP ;
Biocompatible per ISO 10993-1 battery of
tests for Externally Communicating Blood
Path Indirect Contact for prolonged
periods >24 hours. | Particle Counts less than limits for
Large Volume Injections per USP
; Biocompatible per ISO 10993-1
battery of tests for Externally
Communicating Blood Path Indirect
Contact for prolonged periods >24
hours. | Identical |
| Interaction with
Other Medical
Technology | CoStorSol® plus G is not intended for
continuous perfusion. Standard
transplantation surgical expertise and
techniques are required. | CoStorSol® is not intended for
continuous perfusion. Standard
transplantation surgical expertise and
techniques are required. | Identical |
Continued next page
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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Test results have shown CoStorSol® plus G to be a biocompatible solution, supplied in flexible solution bags made of laminated plastic with an ethylene-vinyl-acetate (EVA) layer contacting the solution, which have likewise been tested and shown to be biocompatible. The ISO 10993 series of standards were referenced during the planning and execution of all biocompatibility testing,
6
including: cytotoxicity, acute systemic toxicity, dermal sensitization, hemolysis, and intracutaneous reactivity/irritation. Particulate matter does not exceed the limits set in USP Section , for large volume injections.
The 1 Liter of CoStorSol®, and the single vial of glutathione, are both supplied sterile and nonpyrogenic in order to assure safety for transplant recipients.
Sterilization processes for CoStorSol® plus G were validated according to the ISO 13408 series applicable to aseptic filling, or the ISO 11137 series of standards application to radiation sterilization, as appropriate.
Preservation Solutions, Inc. has validated shelf life for CoStorSol® plus G using a combination of accelerated aging and natural aging protocols, supporting expiry periods of up to 1 year. Shelf life verification tests show that aged CoStorSol® plus G remains functionally equivalent to newly manufactured solution via tests for biocompatibility, particulate matter, chemical identity, general appearance, weight loss, and package integrity.
CONCLUSION
The above statements establish substantial equivalence between the predicate CoStorSol® product, and CoStorSol® plus G.