(64 days)
Not Found
No
The device description and intended use focus on mechanical features for drug delivery and needle-stick prevention. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is intended for the delivery of U-100 insulin or Tuberculin, which are therapeutic substances. The device itself is a syringe designed for the administration of these treatments.
No
Explanation: The device is intended for the delivery of U-100 insulin or Tuberculin, not for diagnosing any condition. Its features focus on drug delivery and needle-stick prevention.
No
The device description clearly states it consists of a sterile syringe, needle, and safety shield, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of U-100 insulin" and "delivery of Tuberculin." This describes a device used to administer substances into the body, not to test samples from the body to diagnose or monitor a condition.
- Device Description: The description details a syringe with a needle and safety shield. This is consistent with a device used for injection, not for performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing or monitoring a condition outside of the body.
Therefore, this device falls under the category of a medical device used for drug delivery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Product codes
MEG
Device Description
The proposed device consists of a sterile syringe, labeled for either U-100 Insulin or Tuberculin, with a permanently attached single lumen needle, and an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip or thumb operation or by pressing the shield. Once activated, the safety shield is securely and permanently locked.
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
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)
Nonclinical Testing: Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
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EXHIBIT # 7
AUG - 3 2006
510(k) Summary
In accordance with section 513(l) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: May 19, 2006
- Contact Person 1.
Michelle Kelley Requlatory Affairs Associate (508) 261-8530
2. Name of Medical Device
Classification Name: Syringe, Antistick
Common or Usual Name: Syringe with Sharps Injury Prevention Feature.
3. Identification of Legally Marketed Device
The proposed Kendall Monoject® Safety Syringe is substantially equivalent in intended use, design and function to the Kendall Monoject@Safety Syringe 510(k) No. K922522.
র্বা Device Description
The proposed device consists of a sterile syringe, labeled for either U-100 Insulin or Tuberculin, with a permanently attached single lumen needle, and an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip or thumb operation or by pressing the shield. Once activated, the safety shield is securely and permanently locked.
Device Intended Use 5.
The proposed device is primarily intended for delivery of U-100 Insulin or Tuberculin, as indicated. The safety shield is designed to protect against sharps injuries when activated.
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6. Product Comparison
The proposed device has the same technological characteristics as the predicate devices. Each device consists of a sterile syringe, a permanently attached single lumen needle, with a manually operated safety feature.
7. Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2006
Ms. Michelle Kelley Regulatory Affairs Associate Tyco Healthcare 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K061492
K061492
Trade/Device Name: Kendall Monoject Magellan Insulin and Tuberculin Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 19, 2006 Received: May 31, 2006
Dear Ms. Kelley:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becalon 910(c) proceed.
referenced above and have determined the device is substantially equivalent (for the referenced above and have determined are to legally marketed predicate devices marketed in indications for use stated in the cholorary to regionent date of the Medical Device interstate comments, or to tvay 20, 1978, and can reclassified in accordance with the provisions of Amendments, of to devices that have occil recisisters approval of a premaired the Federal Pood, Drug, and Cosmetto i corely, market the device, subject to the general approval appreation (1 Mrry. - Four general controls provisions of the Act include controls provisions of the Fea. "The gasting of devices, good manufacturing practice, requirements for hibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Coderel your device can be found in the Code of Peacharters concerning your device in the Eederal Register.
3
Page 2 -- Ms. Kelley
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issualled of a bustant in the requirements
mean that FDA has made a determination that your device the Federal agencies mean that FDA has made a decemination and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered to spaintestic of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and manufacturing propotios Y ou must comply with an the Act 3 requirements art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rart 800); and i and listing (21 CFR Fall 807), labeling (21 CFR Part 820); and if at in 1820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821); at t requirements as set form in the quality systems (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 5 10(k) I his letter will anow you to begin maliceant 3 your device of your device to a premarket notification. The PDA milling of cassimination 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), a If you desire specific advice for your de recolor of the may of any presence the regulation prease contact the Other or Comphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Kendall Monoject Magellan Insulin Safety Syringe Device Name:
Indications For Use:
The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhs (hys. f. How
n of Anesthesiology, General Hospital, otion Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
5
Indications for Use
510(k) Number (if known):
Kendall Monoject Magellan Tuberculin Safety Syringe Device Name:
Indications For Use:
The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
fles C. Aley for mw 8/3/2002
on Sign-Off) on of Anesthesiology, General Hospital,
Page 1 of