(71 days)
Not Found
Not Found
No
The description focuses on hardware modifications, increased memory, expanded programming options for basal rates and bolus delivery patterns, and language options. There is no mention of algorithms that learn or adapt based on data, which are characteristic of AI/ML.
Yes.
The device is an insulin pump used for the continuous delivery of insulin for the management of diabetes, which is a therapeutic purpose.
No.
The device is described as an insulin pump for the continuous delivery of insulin to manage diabetes mellitus. It does not mention any function for diagnosing a medical condition.
No
The device description clearly details hardware components like an application-specific integrated circuit (ASIC), memory, and a screen, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, the MiniMed insulin pump, model 507c, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the continuous delivery of insulin for the management of diabetes. This is a therapeutic function, delivering a substance into the body.
- Device Description: The description details a "rac-programmable syringe infusion pump" designed for delivering insulin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such function. The device is focused on delivering a substance into the body.
Therefore, the MiniMed insulin pump, model 507c, is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The MiniMed insulin pump, model 507c, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellius in persons requiring insulin.
Product codes
LZG
Device Description
The 507c career insulin pump is a user-programmable syringe infusion pump, designed for continuous delivery of insulin, at set and variable rates, as prescribed by the user's physician. The 507c is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood or blood products. The principal modifications described in this submission are: 1) Several of the pump electronics have been integrated into an application specific integrated circuit (ASIC). Approximately 12 K of memory has been added to the Random Access Memory. The device now stores the last 90 days of basal and bolus delivery information, compared with three days in the memory. The memory will also store the last 200 events and last 50 alarms, as well as the device serial number. 2) The basal rate option has been increased. The user may now program up to 48 basal rates, compared with 12. 3) The delivery capacity has been increased. The 507c may deliver up to 35.0 units per hour, compared to 25.0; 4) A screen has been added to account for the priming bolus. This is a new feature that is intended to discount from the delivery history insulin used to prime the infusion set(s) but not actually delivered to the patient; 5) A "Dual Wave" bolus delivery pattern has been added, which allows the device user to program the pump to deliver a percentage of the bolus immediately, with the rest to be delivered in a diminishing manner over time; 6) A new screen has been added to allow the language the user wishes the pump to use in presenting messages. Currently, only English is offered; however, in the future other language options will be provided. The likely languages include French, German, Spanish, Italian, and possibly others. This is designed to address the needs of device users more comfortable with languages other than English.
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
Physician / 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
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)
MiniMed model 507 Insulin Pump.
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
Minimed inc. Premarkel Notification [ SIM(k)] 507c Insulin Pump
K9-72107
Part F. 510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 C.FR 807.92, a 510(k) Summary follows:
Sulvmitter: MiniMed Inc. 12744 Sun Fernando Rd., Sylmar, California 91342
AUG 1 5 1997
Contact: Don Sclvcy, Regulatory Affairs (818) 362-5958, 3011; (520) 527-0107 (v/1).
Name of Device: MiniMcd model 507c Insulin Pump
Predicate Device: MiniMod model 507 Insulin Pump.
Description of the Device: The 507c career insulin punp is a rac-programmable syringe infusion punp, designed for continuous delivery of insulin, at set and variable ratos, as prescribed by the user's plysician. The 507c is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood or blood products. The principal modifications described in this submission are:
- Soveral of the purnp electronics have been integrated into an application spacific intograted circuit (ASIC) Approximately 12 K of momory has been added to the Random Access Memory. "The device now stores the lust 90 days of basel and bolus delivery information, compared with three days in the momory will also store the last 200 events and last 50 alarms, as well as the device serial number. 2) The basal rate option has been increasod. The user noy now program up to 48 basal rates, compared with 12, 3) The delivery capacity has been increased. The 507c may deliver up to 35.0 units per hour, compared to 25.0; 4) A sereen has been added to account for the priming bolus. This is a new feature that is intended to discount from the delivery history insulin used to primo the infusion sol(9) but not actually delivered to the patient; 5) A "Dual Wave" bolus delivery pattern has been added, which allows the device were to program the pump to deliver a percentage of the bolus immediately, with the rest to be delivered in a diminishing nauch over time: () A new screen has been added to allow the language the wishes the wishes the pump to use in presenting messages. Currently, only English is offered: novever, in the fitture other language options will be provided. The likely languages include French, German, Spanish, Judius, and possibly others. This Is designed to address the needs of device users more comfortable with languages other than English.
Intended Use of the New Device: The 507c is intended for continuous delivery of insulin, at set and variable rates, for the management of dialets mellius in persons requiring insulin. It is not intended for use with blood or blood products.
Comparison of the Technological Features of the New Device and Prodicate Device: 77hc technological features of the new device do not differ from the prodicate device. Both devices have the same materials, product design, and chergy source. The electronics have been callanced in the now device.
Don Selvey
Regulatory Affairs
MiniMed Inc.
7-31-97
date
12744 Sau Temando Road • Sylmar. CA 91349 • (800) 933 33327 • [816] 364-2246 • • Mrb Site: http://www.minined.com
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Mr. Don Selvey Regulatory Affairs MiniMed Technologies, Incorporated : 12744 San Fernando Road Sylmar, California 91342
Re: K972107 MiniMed Infusion Pump, Model 507C Regulatory Class: II Product Code: LZG Dated: June 3, 1997 Received: June 5, 1997
Dear Mr. Selvey:
This letter corrects our substantially equivalent letter dated August 1, 1997.
We have reviewed your Section 510(k) notification of intent to market the device reference above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Druq Administration (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
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Page 2 - Mr. Selvey
obliqation you miqht have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general quidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Suite 405 (HFZ-544) 1801 Rockville Pike 20852 Rockville, Maryland
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301 (q) (1) (C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under
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Page 3 - Mr. Selvey
section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639."
In addition, on August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-326) at (301) 594-4639. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
by A. Ulatowski Tim Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number: 《S7 2107
Device Name: MiniMed insulin pump, model S07c
Indications for Use: The MiniMed insulin pump, model 507c, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellius in persons requiring insulin.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Patricia Crucente |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K982107 |
| Prescription Use | |
| (Per 21 CFR 801.109) |
or Over-the-Counter Use్లో