(55 days)
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No
The document describes a replacement battery and contains no mention of AI or ML technology.
No
The device is a replacement battery for infusion pumps, not a therapeutic device itself.
No
Explanation: The device is a replacement battery for infusion pumps. Its intended use is to power existing medical equipment, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a "Rechargeable Battery Part Number 2116," which is a hardware component, 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 clearly stated as a "Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps". This is a power source for a medical device, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: It's described as a "Rechargeable Battery".
- 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.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is a component of a medical device (an infusion pump), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.
Product codes
MOZ
Device Description
Nordix Rechargeable Battery Part Number 2116
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Ms. Marian Lisak Manager Nordix, Incorporated 6831 North 21st Avenue Phoenix, Arizona 85015
Re: K013133
Trade/Device Name: Nordix Rechargeable Battery Part Number 2116 Regulation Number: 880.5725 Regulation Name: Rechargeable Battery Assembly Sealed Lead Acid Regulatory Class: II Product Code: MOZ Dated: September 10, 2001 Received: September 19, 2001
Dear Ms.Lisak:
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.
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
1
Page 2 - Ms. Lisak
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 and ibsing (21 CF CF rate of 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 lexally 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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" (21CFR 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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
NOV 1 3 2001
510(K) Number
Device Name
Nordix Rechargeable Battery Part Number 2116
Indications for use:
Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps
This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.
Pabiosa Cunite
(Division Sign-Off) (Division Sign-Om)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Demail Hospital Devices 510(k) Number -