← Product Code [MRH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH) · K971067

# DIGI-INJECTOR (K971067)

_Medical Instrument Development Laboratories, Inc. · MRH · Sep 19, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K971067

## Device Facts

- **Applicant:** Medical Instrument Development Laboratories, Inc.
- **Product Code:** [MRH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH.md)
- **Decision Date:** Sep 19, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5725
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The Digi-Injector is indicated for use as a general purpose injector of fluids. It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.

## Device Story

Digi-Injector is a fluid injection device designed for precise control of injection rate and volume. Used in clinical settings, including ophthalmic surgery, for both high and low viscosity fluids. Operates with single-use, disposable needles of any gauge. Provides clinicians with controlled fluid delivery to assist in surgical or general injection procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

General purpose fluid injector; compatible with standard single-use disposable needles; designed for precise rate and volume control; suitable for high and low viscosity fluids.

## Regulatory 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.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 19 1997

Mr. Julian M. Cortella
Sr. Mechanical Engineer
Medical Instrument Development Laboratories, Inc.
14477 Catalina St.
San Leandro, CA 94577

Re: K971067
Trade Name: Digi-Injector
Regulatory Class: II
Product Code: 86 MRH
Dated: April 28, 1997
Received: May 5, 1997

Dear Mr. Cortella:

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 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 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.

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Page 2 - Mr. Julian M. Cortella

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/dsmamain.html".

Sincerely yours,

![img-0.jpeg](img-0.jpeg)

A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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9-17-1997 2:59PM FROM MID LABS 510 357 1582 P. 3

Page 1 of 1

September 16, 1997

510(k) Number: K971067
Device Name: Digi-Injector

## INDICATIONS FOR USE

The Digi-Injector is indicated for use as a general purpose injector of fluids. It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Erenette R. Deen
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971067

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)

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