(56 days)
Not Found
None
No
The 510(k) summary describes a replacement battery pack and contains no mention of AI, ML, or related technologies.
No
Explanation: This device is a replacement battery pack for feeding pumps, not a feeding pump itself. While feeding pumps can be considered therapeutic devices, a battery pack is a component, not a standalone therapeutic device.
No
The device is a replacement battery pack for a feeding pump, which is not a diagnostic device. It does not measure, analyze, or interpret physiological data for diagnosis.
No
The device description explicitly states it is a "Replacement battery pack," 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/Indications for Use: The intended use is clearly stated as a "Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH". This describes a power source for medical devices, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description confirms it's a "Replacement battery pack".
- 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 intended to power other medical devices (feeding pumps and an intri-flush device). These are medical devices themselves, but the battery pack is an accessory, not an IVD.
N/A
Intended Use / Indications for Use
Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Product codes
MRZ, MOQ
Device Description
Not Found
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
biomedical equipment technicians and or customers
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2001
Mr. Don Pelletier President National Custom Enterprises, Incorporated 1133 East Cliff Road Burnsville, Minnesota 55337
Re: K012266
Trade/Device Name: Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N Regulation Number: 880.5725 Regulation Name: Pump, Infusion, Eternal; Accessory-Replacement Battery Pack Regulatory Class: II Product Code: MRZ and MOQ Dated: July 11, 2001 Received: July 18, 2001
Dear Mr. Pelletier:
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
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Page 2 - Mr. Pelletier
of the Act or any Federal statutes and regulations administered by other Federal agencies. or are recordly with all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifoung (22 early in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
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 premilated 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) 594-4618. 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 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,
La Cluturat
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
Applicant: National Custom Enterprises, Inc. (800) 328-3773
510(k) Number: 仏のアプレビ
N7213IWC2 Device Name:
Indications For Use: Replacement battery pack for
SHERWOOD 224, 324 FEEDING PUMP &
SHERWOOD K524 INTRI-FLUSH
This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Vittorio Lucente
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __
OR