(57 days)
Sherwood Monoject® Safety Syringe (1, 3, 6 and 12 cc sizes)
Not Found
No
The device description and performance studies focus on mechanical features for sharps injury prevention, with no mention of AI or ML.
No.
The device is indicated for fluid transfer and designed to prevent needlestick injuries, not to treat or diagnose a medical condition in a patient.
No
The device is a self-sheathing hypodermic needle designed for fluid transfer and to prevent needlestick injuries, not to diagnose medical conditions.
No
The device description clearly details a physical hypodermic needle with a spring-loaded shield mechanism, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock)." This describes a device used for handling and transferring fluids outside of the body, not for testing or analyzing samples taken from the body.
- Device Description: The description focuses on the mechanical function of the needle and shield for safe fluid transfer. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to diagnostic tests, assays, or the detection of specific substances.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is purely for safe fluid handling in a clinical setting.
N/A
Intended Use / Indications for Use
The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The SelfShield HN™ device incorporates a standard hypodermic needle which adapts to piston syringe standard luer fittings. The device embodies a spring loaded needle shield which automatically covers the needle tip prior to and after each use. It helps reduce the occurrence of accidental needlesticks to healthcare workers when the product is used as directed. The user activates the device by placing the tip of the shield against a rubber injection site, clockwise rotating the device by at least 40° and pushing the shield back until the needle tip penetrates into and beyond the injection site rubber plug. Once fluid, drug, agent or blood is drawn, the unit is removed from the injection site. The needle shield automatically advances covering and protecting the sharp tip for transport. The device is reactivated again against another injection site until disposed in an approved sharps container. The device is supplied sterile in a peelable Tyvek-nylon blister package.
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
The SelfShield HN™ device was tested in a simulated clinical test by experienced users of the predicate device. It performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature and therefore meets the test requirements of the FDA guidance document on devices with sharps injury prevention features. The SelfShield HNTM needle was rated as very effective (score =10) by 50% and is generally rated as acceptable (score =8 and above) by 93% of the user-evaluators, who were positive about the safety and ease of use of the device. They indicated that it will repeatedly transfer fluids aseptically until easily disposed of in a sharps container and that users can be easily trained on the technique. Analysis of the data demonstrates that it can be used effectively by either left or right handed users. Among users who currently use the predicate device, the SelfShield HNTM device was rated as easier and requiring less time to use by the majority of user-evaluators and recommending it 98% of the time than the predicate device for fluid transfer applications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results from comparative bench tests indicate that tensile loads needed to separate the shield from either the SelfShield HNTM unit or the predicate device are more than adequate in reducing the potential for failure by pulling since the loads are well above the force that can be reasonably applied by hand in a clinical setting. The SelfShield HN™ device's peak compressive load needed to expose the needle tip is approximately 10 times higher than the predicate device while in the temporary locked position. Therefore, when transporting a filled syringe the SelfShield HN™ unit requires substantially more force to override the lock compared to the predicate device, which relies on a less robust detent feature to hold the shield in position during transport. The SelfShield HN™ device was tested in a simulated clinical test by experienced users of the predicate device. It performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature and therefore meets the test requirements of the FDA guidance document on devices with sharps injury prevention features.
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.
Sherwood Monoject® Safety Syringe (1, 3, 6 and 12 cc sizes)
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
Image /page/0/Picture/0 description: The image shows the word "BEECH" in a stylized, bold font. The letters are enclosed within a rounded rectangular shape. There is a registered trademark symbol to the bottom right of the letter H.
K 77 2467
510(k) Summary
Date: 30 June 1997
AUG 27 1997
Contact Name: John Romano, President
Submitter: Beech Medical Products, Inc. 241 Lackland Drive Middlesex, NJ 08846 tel: 908-563-0303 fax: 908-563-1115
Proprietary Name: SelfShield HNTM Self Sheathing Hypodermic Needle
Common Name: Shielded Hypodermic Needle
Classification Name: Hypodermic Single Lumen Needle
Predicate Device: Sherwood Monoject® Safety Syringe (1, 3, 6 and 12 cc sizes)
The SelfShield HN™ device incorporates a standard hypodermic needle which adapts to piston syringe standard luer fittings. The device embodies a spring loaded needle shield which automatically covers the needle tip prior to and after each use. It helps reduce the occurrence of accidental needlesticks to healthcare workers when the product is used as directed. The user activates the device by placing the tip of the shield against a rubber injection site, clockwise rotating the device by at least 40° and pushing the shield back until the needle tip penetrates into and beyond the injection site rubber plug. Once fluid, drug, agent or blood is drawn, the unit is removed from the injection site. The needle shield automatically advances covering and protecting the sharp tip for transport. The device is reactivated again against another injection site until disposed in an approved sharps container. The device is supplied sterile in a peelable Tyvek-nylon blister package.
Both the SelfShield HNTM device and the predicate device use the same hypodermic needle and are gamma sterilized , single patient use, and disposable devices. However, the needle shield of the Self Shield HN™ device automatically extends forward over the needle tip into a terrippary locked position after each use whereas the predicate device's needle shield must be manually extenced forward to the temporary locked position. The automatic return of the shield to the temporary locked position does not require a conscious effort by the user whereas the predicate device does. However, since the needle tip is not exposed so that it can be used to pierce the skin under visual control, the Self Shield HN™ indications are limited to non-skin transfers such as from a drug vial to the injection cap on an IV catheter. On the other hand, the predicate device can be used for both skin and non-skin administration of drugs or direct blood draw since the needle is initially exposed to view.
The results from comparative bench tests indicate that tensile loads needed to separate the shield from either the SelfShield HNTM unit or the predicate device are more than adequate in reducing the potential for failure by pulling since the loads are well above the force that can be reasonably applied by hand in a clinical setting. The SelfShield HN™ device's peak compressive load needed to expose the needle tip is approximately 10 times higher than the predicate device while in the temporary locked position.
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Therefore, when transporting a filled syringe the SelfShield HN™ unit requires substantially more force to override the lock compared to the predicate device, which relies on a less robust detent feature to hold the shield in position during transport. The SelfShield HN™ device was tested in a simulated clinical test by experienced users of the predicate device. It performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature and therefore meets the test requirements of the FDA guidance document on devices with sharps injury prevention features. The SelfShield HNTM needle was rated as very effective (score =10) by 50% and is generally rated as acceptable (score =8 and above) by 93% of the user-evaluators, who were positive about the safety and ease of use of the device. They indicated that it will repeatedly transfer fluids aseptically until easily disposed of in a sharps container and that users can be easily trained on the technique. Analysis of the data demonstrates that it can be used effectively by either left or right handed users. Among users who currently use the predicate device, the SelfShield HNTM device was rated as easier and requiring less time to use by the majority of user-evaluators and recommending it 98% of the time than the predicate device for fluid transfer applications.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, services, and human well-being. 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
电网 27 ppg
Mr. John Romano President Beech Medical Products, Incorporated ----241 Lackland Drive Middlesex, New Jersey 08846
K972469 Re : Selfshield HN Self Sheathing Hypodermic Trade Name: Needle Requlatory Class: II Product Code: FMI Dated: June 30, 1997 Received: July 1, 1997
Dear Mr. Romano:
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 (for the indications for use stated in the enclosure) 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation 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
3
Page 2 - Mr. Romano
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 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" (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,
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
| 510(k) Number (if known): | K 972469 |
|---|---|
| Device Name: | Self Shield HN |
| Indications For Use: |
ﯿﺴﮯ
The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | K978469 |
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
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Over-The-Counter Use________
(Optional Format 1-2-96)
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