NEO-2 METER by AUTOMATA INSTRUMENTATION, INC.

The NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called the "NEO-2 Meter". It indicates that the device has been found substantially equivalent to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The text only states:

Device Name: NEO-2 Meter
Intended Use: To test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems, and the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Regulatory Class: II (21 CFR §876.5820/Product Code: 78 FIZ)
Date of Clearance: October 13, 1999

Therefore, I cannot provide the requested information regarding acceptance criteria and studies because it is not present in the provided text. The output will reflect this lack of information for each requested point.

Acceptance Criteria and Study Information for NEO-2 Meter

Based on the provided document, the following information regarding acceptance criteria and supporting studies for the NEO-2 Meter is not available:

Table of acceptance criteria and reported device performance:
- No acceptance criteria are mentioned in the document.
- No device performance data is reported.
Sample size used for the test set and the data provenance:
- No information about a test set or its sample size is provided.
- No data provenance (country of origin, retrospective/prospective) is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information regarding experts or ground truth establishment is provided.
Adjudication method for the test set:
- No information regarding a test set or adjudication method is provided.
Multi-reader multi-case (MRMC) comparative effectiveness study and effect size:
- No MRMC study or comparative effectiveness data is mentioned.
Standalone (algorithm-only) performance:
- The NEO-2 Meter is a physical measurement device, not an AI/algorithm-based device in the context typically described by "standalone performance." Therefore, this question is not applicable, and no such study is mentioned anyway.
Type of ground truth used:
- No information about the type of ground truth is provided.
Sample size for the training set:
- This question is typically relevant for machine learning models. As the NEO-2 Meter is a measurement device, a "training set" in this context is not applicable. No information about any training data is provided.
How the ground truth for the training set was established:
- As with point 8, this is not applicable for this type of device, and no relevant information is provided.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

OCT 1 3 1999

Ms. Linda V. Masano President AUTOMATA Instrumentation, Inc. 15600 North 78th Street Scottsdale, AZ 85260-1735

Re: K992431 NEO - 2 Meter Dated: July 20, 1999 Received: July 21, 1999 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 FIZ

Dear Ms. Masano:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AUTOMATA

NEO-2 Premarket Notification

INDICATIONS FOR USE STATEMENT G.

Indications for Use Statement

K992431 510(k) Number (if Known): _

Device Name: NEO-2 Meter

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use

David A. Stypmann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Regulation Number and Section

§ 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.