(71 days)
Not Found
No
The device description and intended use focus on a mechanical safety mechanism for a needle, with no mention of AI or ML technologies.
No.
The device is an accessory (a needle) used for the administration of insulin from a delivery device, not a therapeutic device itself. Its primary function is to facilitate the delivery of a therapeutic substance, and it also includes a safety feature to prevent needlesticks.
No
Explanation: The device, NovoFine® Autocover™ 30G x 8 mm needles, is used for injection and not for diagnosis. Its description and intended use clearly state its function is for "subcutaneous administration of sterile parenteral insulin products" and provide safety features for handling, not for detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly details a physical needle and safety shield mechanism, indicating it is a hardware device, not software-only.
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 subcutaneous administration of insulin and to minimize the risk of accidental needlestick after injection. This is a therapeutic and safety function related to drug delivery, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical mechanism of the needle and its safety feature for injection and disposal. It does not describe any process of analyzing biological samples.
- 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.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly designed for the delivery of medication and the prevention of needlestick injuries, which falls under the category of a medical device used for treatment and safety, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The NovoFine® Autocover™ 30G x 8mm needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle cap is removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.
After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine Autocover by using the needle cap as described in the instruction leaflet
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
diabetes nurse educators, diabetes patients and staff nurses
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)
Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses. Differences between the devices tested do not raise any significant issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Page 1 of 3
MAR 3 0 2005
NovoFine Autocover™ 30G Disposable Safety Needle
510(k) Premarket Notification
Date Version:
Status:
17 Jan 2005 Novo Nordist
Final
Novo Nordisk Inc
10 807.87(h) 510(k) Summary
As required by Section 807.92(a)
(1) DATE OF PREPARATION: January 15, 2005
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. NovoFine® Autocover™ 30 G x 8 mm needles meet all applicable product and quality standards for hypodermic single lumen needle products.
SUBMITTER'S NAME AND ADDRESS:
| Novo Nordisk Inc. | Contact Person: John Signorini |
|---|---|
| 100 College Road West | Tel: 609-987-5967 |
| Princeton, New Jersey 08540 | Fax: 609-987-3916 |
(2) NAME OF DEVICE:
| Proprietary Name: | NovoFine® Autocover™TM 30G x 8 mm needles |
|---|---|
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification: | Hypodermic single lumen needle |
| Class: | Class II |
(3) SUBSTANTIAL EQUIVALENCE:
The NovoFine® Autocover™ 30G x 8 mm needle is substantially equivalent to the Novo Nordisk NovoFine® 31G x 6 mm needle (K002403) which was cleared by FDA in December 2000 and the Becton Dickenson BD SafetyGlide™ 25G x 16mm needle (K951254) which was cleared by FDA in October 1995.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the
1
| NovoFine* Autocover™ 30G
Disposable Safety Needle
Novo Nordisk Inc | 510(k) Premarket Notification | Date:
Version:
Status | 17 Jan 2005
1
Final | Novo Nordisk |
| ------------------------------------------------------------------------------ | ------------------------------- | ----------------------------- | --------------------------- | -------------- |
|---|
807.87(h) 510(k) Summary (continued)
resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent laws or their application by the court.
(4) DEVICE DESCRIPTION:
The NovoFine® Autocover™ 30G x 8mm needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle cap is removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.
After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine Autocover by using the needle cap as described in the instruction leaflet
(5) INTENDED USE:
The intended use for the modified device remains the same as the predicate devices (NovoFine® 31G x 6 mm and BD Safety Glide 25G x 16 mm):
For use in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
2
| NovoFine Autocover™ 30G
| Disposable Safety Needle | 510(k) Premarket Notification | Date: | 17 Jan. 2005 | Novo Nordisk |
|---|---|---|---|---|
| Version: | 1 | |||
| Status: | Final |
Novo Nordisk Inc.
807.87(h) 510(k) Summary (continued)
(6) TECHNOLOGICAL CHARACTERISTICS:
The NovoFine® Autocover™ 30G needle is substantially equivalent to the NovoFine® 31G and BD SafetyGlide 25G needle in intended use, technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.
Section 807.92(b)
(1) NON-CLINICAL TESTS PERFORMED:
The NovoFine® Autocover™ 30G needles will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices. Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards.
(2) CLINICAL TESTS SUBMITTED:
Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses. Differences between the devices tested do not raise any significant issues of safety and effectiveness.
(3) CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS:
Based on the design equivalency and the functional and safety testing, Novo Nordisk had determined that the NovoFine® Autocover™ 30G x 8 mm needles are substantially equivalent to the devices currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.
M.U. McElroy, Ph.D., R.E.t.
Barry Reit, PhD Vice President, Regulatory Affairs & Quality Assurance Novo Nordisk Inc.
1/17/05
Date
Date
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2005
Mr. John Signorin Manager, Regulatory Affairs Novo Nordisk. Incorporated 100 College Road West Princeton, New Jersey 08540
Re: K050106
Trade/Device Name: NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 17, 2005 Received: January 18, 2005
Dear Mr. Signorin:
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.
4
Page 2 - Mr. Signorin
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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Sylitte Michau Oms.
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
5
| NovoFine® Autocover™ 30G
Disposable Safety Needle
Novo Nordisk Inc. | 510(k) Premarket Notification | Date:
Version:
Status: | 17 Jan 2005
1
Final | Novo Nordisk |
| ------------------------------------------------------------------------------- | ------------------------------- | ------------------------------ | --------------------------- | -------------- |
|---|
Indication for Use Statement 2
| 510(k) Number (if known) | Not available K050106 | |
|---|---|---|
| Device Name: | NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle | |
| Indications For Use: | NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick. | |
| 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)
C. Alan Brock
rsion Sim-Off) Chision of Anes hestology, General Hospital, Intection Control Dental Devices
Number. K050106
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