(99 days)
Not Found
No
The description focuses on a physical heat exchange mechanism and standard safety/performance testing, with no mention of AI/ML terms or data-driven algorithms.
No
The device warms return blood flow to prevent heat loss, which supports a medical procedure (Prismaflex® treatment) but does not directly treat a disease or condition itself.
No
The device is a blood warmer used to prevent heat loss, not to diagnose a condition.
No
The device description explicitly states it consists of a controller and a sleeve warmer, which are hardware components. The summary also details nonclinical tests related to the performance and safety of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm the return blood flow line during a Prismaflex® treatment to replace heat loss. This is a therapeutic function, not a diagnostic one.
- Device Description: The device description details a blood warmer that physically warms the blood line. It does not mention any analysis of biological samples or diagnostic measurements.
- Lack of Diagnostic Elements: There is no mention of analyzing blood or other biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to prevent cooling and its safety features, not on diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely to warm the blood during a treatment, which is a therapeutic support function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.
Product codes (comma separated list FDA assigned to the subject device)
KOC
Device Description
The Prismacomfort blood warmer consists of one controller and one sleeve warmer. The controller (Barkey autocontrol 3XPT) controls the sleeve warmer (Barkey autoline XPT 4R) and displays alarm and status messages. The Prismacomfort blood warmer warms the returning blood flow line by means of a silicon tube heat exchanger (applied part Barkey autoline XPT 4R) which covers the blood return flow line of the Gambro Prismaflex® system completely. The heat is transferred by the contact of the resistance heating system Barkey autoline XPT 4R to the inserted blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency. The device is intended for the Prismaflex® System and may be used with any of the Prismaflex® system therapy choices, when heat loss may cause undesirable cooling of the patient. The warmer is powerd with 24 VDC which is derived from 115 VAC (or where required 230 VAC), 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Barkey autocontrol 3XPT. Below the on-off switch is a display temperature monitor. The temperature of the sleeve warmer, visual and audible alarms, and other performance characteristics of the sleeve warmer are controlled electronically. The sleeve warmer Barkey autoline XPT 4R is constructed as a slotted enclosed silicon tube which can completely enclose inserted blood return flow lines of up to 6.55 mm diameter. The Prismacomfort weighs approx. 3.7kg and is equipped with a holder at the rear side of the control unit which allows mounting on hemodialysis system Gambro Prismaflex® system. Both products, the Prismacomfort and the Stihler prismaflo use sleeve warmers made of silicon. The flexibility of this material ensures a complete enclosure of the blood return flow line on Gambro Prismaflex® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended to be used only by approriately trained and qualified healthcare professionals and servicing staff in clinical environments.
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)
The Prismacomfort blood warmer complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications.
Verification of compliance with the following mandatory and voluntary standards has been made:
- DIN EN 60601-1
- DIN EN 60601-1-2
- UL 2601-1/10.97
- CAN/CSA-C22.2 No. 601.1-M90
- ASTM F 2172-02
In order to verify performance of the Barkey Prismacomfort blood warmer in support of substantial equivalence, the following tests were carried out:
- Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system.
- Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions.
This shows that there are no new questions of safety and effectiveness for the Prismacomfort blood warmer as compared to the predicate device.
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
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. 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.
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Image /page/0/Picture/2 description: The image shows the logo for Barkey, a company located in Germany. The logo features a stylized electrical plug symbol next to the company name in bold, black font. Below the logo is the company's address: Barkey GmbH & Co. KG, Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The text "page 1 of 4" is handwritten at the top of the image.
| Date: | 2007-10-06 |
|---|---|
| Submitter: | Barkey GmbH & Co. KG |
| Address: | Gewerbestrasse 8 |
| D-33818 Leopoldshoehe | |
| Germany | |
| Contact: | Thomas Barkey |
| Telephone: | |
| Fax: | |
| mail: | +49-5202-9801-0 |
| +49-5202-9801-77 | |
| info@barkey.de | |
| Common Product Name: | Blood Warming Device |
| Trade Name: | Prismacomfort blood warmer |
| Regulation Medical | |
| Specialty (Panel): | Gastroenterology-Urology Devices |
| [21 CFR 876.5820] | |
| Product Code: | KOC |
| Device Class: | 2 |
| Identification of | |
| legally marketed predicate | |
| device to which substantial | |
| equivalence is claimed: | Stihler prismaflo |
| 510(k) Number: K020103 | |
| Stihler Electronic GmbH | |
| Julius-Hoelder-Strasse 36 | |
| D-70597 Stuttgart-Germany | |
| [21 CFR 876.5820] |
OCT 1 8## 2.2 510(k) summary
Address:
[21 CFR 876.5820]
2007
1
Image /page/1/Picture/1 description: The image shows the logo for Barkey, a company located in Germany. The logo features the company name in a bold, sans-serif font, with a stylized plug symbol to the left. Below the logo is the company's name, Barkey GmbH Et Co. KG, followed by their address: Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The image also contains the text 'K071909 page 2 of 4' at the top.
| Brief Description: | The Prismacomfort blood warmer is substantially equivalent in safety andeffectiveness to the legally marketed (predicate)Stihler prismaflo (510(k) Number: K020103). The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat lost to the athmosphere and effluent flow during a Prismaflex® treatment. The Prismacomfort blood warmer consists of one controller and one sleeve warmer. The controller (Barkey autocontrol 3XPT) controls the sleeve warmer (Barkey autoline XPT 4R) and displays alarm and status messages. The Prismacomfort blood warmer warms the returning blood flow line by means of a silicon tube heat exchanger (applied part Barkey autoline XPT 4R) which covers the blood return flow line of the Gambro Prismaflex® system completely. The heat is transferred by the contact of the resistance heating system Barkey autoline XPT 4R to the inserted blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency. The device is intended for the Prismaflex® System and may be used with any of the Prismaflex® system therapy choices, when heat loss may cause undesirable cooling of the patient. |
|---|---|
| Intended Use: | The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment. Federal law restricts this device to sale by or on the order of a physian. It is intended to be used only by approriately trained and qualified healthcare professionals and servicing staff in clinical environments. |
| Summary of the technological characteristics of the Prismacomfort blood warmer: | The warmer is powerd with 24 VDC which is derived from 115 VAC (or where required 230 VAC), 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Barkey autocontrol 3XPT. Below the on-off switch is a display temperature monitor. The temperature of the sleeve warmer, visual and audible alarms, and other performance characteristics of the sleeve warmer are controlled electronically. Like the blood warmer Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany), the sleeve warmer Barkey autoline XPT 4R is constructed as a slotted enclosed silicon tube which can completely enclose inserted blood return flow lines of up to 6.55 mm diameter. The Prismacomfort weighs approx. 3.7kg and is equipped with a holder at the rear side of the control unit which allows mounting on hemodialysis system Gambro Prismaflex® system. Both products, the Prismacomfort and the Stihler prismaflo use sleeve warmers made of silicon. The flexibility of this material ensures a complete enclosure of the blood return flow line on Gambro Prismaflex® System. |
2
Image /page/2/Picture/1 description: The image shows the logo for Barkey, a company located at Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The logo features the company name in bold letters, with two electrical plug symbols on the left side. At the top of the image, there is a handwritten note that says "K071909 page 3 of 4".
Summary of Nonclinical Tests and Results:
The Prismacomfort blood warmer complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- . DIN EN 60601-1
- . DIN EN 60601-1-2
- . UL 2601-1/10.97
- . CAN/CSA-C22.2 No. 601.1-M90
- t ASTM F 2172-02
In order to verify performance of the Barkey Prismacomfort blood warmer in support of substantial equivalence, the following tests were carried out:
- Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system.
- ﺳﮯ Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions.
This shows that there are no new questions of safety and effectiveness for the Prismacomfort blood warmer as compared to the predicate device.
The predicate device (Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany) has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order.
Conclusion: The Prismacomfort blood warmer is substantially equivalent to the Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany, [21 CFR 876.5820]) which received 510(k) approval on April 24, 2002. Both systems have the same intended use, and are capable of heating blood return flow line on Gambro Prismaflex®system. Both systems as intended according to the specifications of the device. The Prismacomfort blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Prismaflo(510(k) Number: K020103).
The Prismacomfort blood warmer has the following similarities to the Prismaflo predicate device:
- have same intended use
- have same fundamental scientific technology and use the same operating priciple
- heating sleeves are constructed of identical materials
- both, the Prismacomfort and the Prismaflo give efficient heat to keep the blood return flow on Gambro Prismaflex® Systems warm.
3
Barkey blood warmer Prismacomfort
Barkey GmbH & Co. KG Gewerbestrasse 8 D-33818 Leopoldshoehe Germany
The main differences between the Prismacomfort blood warmer and the predicate Prismaflo are the structure. Due to the fact that the Barkey Prismacomfort is consisting of one controller and one applied part (the sleeve warmer), the Prismflo is one complete system which means that the warming device is fix connected to the supply part (the controller).
The predicate device (Stihler prismaflo (510{k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany) has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order
In summary the Prismacomfort, described in this conclusion is substantially equivalent to the predicate device Stihler Prismaflo (K020103).
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Image /page/4/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 lines representing its wings or feathers. The eagle faces left within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Mr. Thomas Barkey Managing Director and Safety Officer Barkey GmbH Et Co. KG Gewerbestrasse 8 D-33818 Leopoldshoehe GERMANY
Re: K071909
Trade/Device Name: Prismacomfort blood warmer Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: October 6, 2007 Received: October 10, 2007
Dear Mr. Barkey:
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 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.
5
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 (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.
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 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 CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain 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) 638-2041 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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Image /page/6/Picture/1 description: The image shows the logo for Barkey, along with their address. The address is Barkey GmbH & Co. KG, Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The logo features the word "Barkey" in a bold, sans-serif font, with two electrical plug symbols stacked vertically to the left of the word.
2.1 Indications for Use
Indications for Use
Kozilaoa 510(k) Number (if known): Device Name: Prismacomfort blood warmer Indications for Use: The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number