(70 days)
The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.
The proposed device consists of a sterile, single-lumen hypodermic needle with 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 operation or by pressing the shield against a hard surface. Once activated, the safety shield is securely and permanently locked.
The Kendall Monoject® Safety Needle is a hypodermic needle with a sharps injury prevention feature.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative format, nor does it report specific numerical performance metrics for the device's efficacy in preventing sharps injuries. Instead, it focuses on demonstrating biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility according to ISO 10993-1 and FDA modified matrix | Device meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size or details of the test set used for the biocompatibility testing. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study is a non-clinical biocompatibility test, not one involving expert review of medical images or diagnoses to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable for a biocompatibility study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document refers to "Nonclinical Testing" for biocompatibility, not a clinical study involving human readers or comparative effectiveness with AI.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. This device is a physical medical device (hypodermic needle), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the biocompatibility testing would be adherence to the established scientific guidelines and benchmarks outlined in the ISO 10993-1 standard and FDA's modified matrix for biological evaluation of medical devices. This is based on standardized scientific protocols and laboratory testing rather than expert clinical consensus, pathology, or outcomes data in the typical sense of AI studies.
8. Sample Size for the Training Set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
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EXHIBIT # 11
OCT 2 5 2001
510(k) Summary
In accordance with section 513(I) 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: August 10, 2001
- Contact Person 1.
David A. Olson Director, Regulatory Affairs (508) 261-8530
2. Name of Medical Device
Classification Name: Needle, Hypodermic, Single Lumen
Common or Usual Name: Hypodermic Needle with Sharps Injury Prevention Feature.
Identification of Legally Marketed Device 3.
The proposed Kendall Monoject® Safety Needle is substantially equivalent in intended use, design and function to Becton Dickinson's SafetyGlide™ Needle, 510(k) No. K951254 and the Concord/Portex (Sims) Needle-Pro®, 510(k) No. K911037.
4. Device Description
The proposed device consists of a sterile, single-lumen hypodermic needle with 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 operation or by pressing the shield against a hard surface. Once activated, the safety shield is securely and permanently locked.
5. Device Intended Use
The proposed device is primarily intended to inject fluid into, or withdraw fluid from the body. 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 rne proposed it with the consists of a hypodermic needle with a manually operated safety feature.
Nonclinical Testing 7.
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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines, possibly representing a stylized bird or abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2001
Mr. David A. Olson Director, Regulatory Affairs Tyco Healthcare 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K012736
Trade/Device Name: Monoject Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: Class II Product Code: FMI Dated: August 15, 2001 Received: August 16, 2001
Dear Mr. Olson:
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 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
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Page 2 - Mr. Olson
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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 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 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
Since
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K012736 510(k) Number (if known):___
Kendall Monoject Safety Needle
Device Name:_
Indications For Use:
The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Crescentz
on of Dental, Infection Control. and General Hospital Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
. . . . . . . .
ાર
Over-The-Counter Use_ ...
(Optional Formal 1-2-96)
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).