(63 days)
Not Found
No
The description focuses on basic measurement functions and a simple user interface, with no mention of AI/ML terms or capabilities.
No
Explanation: The device is used to test the properties of dialysate solutions and water; it does not directly treat a medical condition or perform a therapeutic function on a patient.
No.
The device tests properties of the dialysate solution itself, not the patient. While this solution is used in a medical treatment, the device is not used to diagnose a medical condition in a patient.
No
The device description explicitly mentions hardware components such as a Digital Liquid Crystal Display, waterproof key membrane, and keys for operation, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the HDM97 is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems." It also mentions testing "conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications." These are tests performed on samples outside of the human body (in vitro) to provide information relevant to a medical condition or treatment (hemodialysis).
- Nature of the Tests: Measuring conductivity, temperature, pressure, and pH of dialysate solutions are all analytical tests performed on a substance used in a medical procedure.
While the device description focuses on the physical characteristics and user interface, the core function described in the intended use aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems.
The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Product codes (comma separated list FDA assigned to the subject device)
78 FIZ
Device Description
The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications.
The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off.
The software is designed to be logical and easy to use for the user either safe and precise in measurement.
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
hemodialysis personnel
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
§ 876.5820 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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MAY 2 2 2002
KO20908 PAGE 1 OF 3
Image /page/0/Picture/2 description: The image shows a logo with the letters "IBP" in a stylized font. The "I" is represented by a black square with a white diagonal line running through it. The letters "B" and "P" are outlined in black, with a white fill. The logo is simple and modern, and the use of black and white gives it a bold and graphic look.
Premarket Notification 510(k) Summery
HDM97 Dialysis Meter
June 22, 2001
Applicant's and manufacturing address
IBP Instruments GmbH Sutelstr. 7A 30659 Hannover Germany
Dipl. Ing Werner Pfingstmann
Phone +49 511 651647 +49 511 652283 Fax
Werner Pfingstmann
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Image /page/1/Picture/1 description: The image shows a logo with the letters "IBP" in a stylized font. The "I" is connected to a black square with a white diagonal line. The letters are outlined in black, with a white fill. The logo has a simple, modern design.
Page : 2 of : 3
Substantial Equivalence
Predicate Device
Neo2 meter - 510(k) Number: K992431
Automata Instrumentation, Inc. 7830 East Redfield Road #12 Scottsdale, Arizona 85260 USA
Description of the device
The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications.
The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off.
The software is designed to be logical and easy to use for the user either safe and precise in measurement.
Intended use
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems.
The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Technological characteristics HDM97 - Predicate device
Comparsion Table
| Neo2 meter | HDM97 | |
|---|---|---|
| Measuring | ||
| Conductivity | Yes | Yes |
| Temperature | Yes | Yes |
| Pressure | Yes | Yes |
| pH | Yes | Yes |
| Microprocessor controlled | Yes | Yes |
| RS232-Interface | No | Yes |
| Power supply | Battery | Rechargeable Battery |
The technological characteristics of the HDM97 and the predicate device are completely identical.
2
Image /page/2/Picture/0 description: The image shows a logo with a black square on the left side. Inside the square, there are two white triangles that are separated by a black line. To the right of the square, there are the letters "IBP" in a stylized font. The letters are outlined in black and filled with white.
HDM97 – Premarket Notification 510(k) Summery
Page : 3 of : 3
Additional
In over 17 years of developing, manufacturing, marketing and servicing meters for In over 17 years or developing, manational shown your involving patient's or dialysis, no adverse meldents nave ever been well thought out, and proven Staff Salety. The Safety Innerent in the design has been by the market for many years.
3
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 representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
MAY 2 2 2002
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IBP Instruments GMBH c/o Mr. Mark Job TPR Project Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K020908 Trade/Device Name: HDM 97 (non-remote conductivity meter) Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIZ
Dated: May 6, 2002 Received: May 7, 2002
Dear Mr. Job:
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 (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.
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
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Indications for Use Statement
510(k) Number __
Device Name: HDM97
Indication for Use:
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems.
The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
David A. Ligman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __ 12041