(65 days)
MOOlo Replacement Battery
The provided text is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for a replacement battery, and an "Indications For Use" statement.
Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter is an FDA determination of substantial equivalence for a replacement battery (Part no. M006) to a predicate device, as required for marketing in the United States. It references previous 510(k) numbers for the devices the battery replaces.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval letter, not a study report or technical specifications document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Mr. Ken Heimendinger Alexander Manufacturing Company ... ... . . ..... P.O. Box 1508 1511 South Garfield Place Mason City, Iowa 50401
Re: K971240
Replacement Battery (Part no .- M006) ... . . . . Dated: April 21, 1997 Received: April 24, 1997 Regulatory class: II 21 CFR §884.2660/Product code: 85 HEL
14 Dear Mr. Heimendinger:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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) 594-4616. 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/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductive. Abdominal, Ear, Nose and Throath and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ___ K 9 71240
Device Name: MOOlo Replacement Battery
Indications For Use:
Replaces R&D Batteries part Number 5164 (K933687 and K951403)
which are used in Sonicaid fetal heart monitors D100RE, D102R
PN 1000-0006 K#873673.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robat R Sullmi
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971240
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).