(99 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and do not mention any AI or ML components.
No
The device is an accessory for pre-filled syringes designed to prevent needlestick injuries, not to treat a medical condition or disease.
No
Explanation: The device is described as an accessory for pre-filled syringes designed to prevent accidental needlesticks. Its function is to protect users from injury, not to diagnose any medical condition.
No
The device description clearly states it is a physical accessory consisting of a subassembly and a clip, designed to be assembled with a pre-filled syringe. It is a hardware device for sharps injury prevention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for pre-filled syringes to prevent needlestick injuries. This is a safety feature for administering medication, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical system designed to cover a needle after injection. This aligns with a safety device for drug delivery, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device's function is purely mechanical and related to the safe delivery of medication via injection.
N/A
Intended Use / Indications for Use
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Product codes
MEG
Device Description
The proposed device, NovaGuard SA Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8" The NovaGuard SA Safety System consist of two components, a subassembly (syringe holder, sleeve and spring) and a clip. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.
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
unrestricted and may include children and adults
Intended User / Care Setting
healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients
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
Bench testing was performed on the proposed device, NovaGuard SA Safety System. It was confirmed that the device functioned as intended.
Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited (
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
West Pharmaceutical Services C/O Mr. Kevin Lentz Director of Regulatory Affairs/PDS Group 530 Herman O. West Drive Exton, PA 19341
Re: K141464
Trade/Device Name: NovaGuard SA Safety System Regulation Number: 21 CFR 880.5860 Regulation Name: Syringe, Anti Stick Regulatory Class: II Product Code: MEG Dated: August 13, 2014 Received: August 15, 2014
Dear Mr. Lentz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Lentz
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Digitally signed by Richard C. Chapman -S Date: 2014.09.10 12:39:17 -04'00'
for
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K141464
Device Name NovaGuard SA Safety System
Indications for Use (Describe)
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY 5
NovaGuard SA Safety System Device:
Company Name:
West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: (610) 594-3105
Contact Person:
Kevin Lentz Director of Regulatory Affairs/PDS group West Pharmaceutical Services, Inc. Phone: 610-594-4353 Fax: 610-717-0668 E-mail: kevin.lentz@westpharma.com
US Agent:
Kevin Lentz Director of Regulatory Affairs/PDS group West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: 610-594-4353 Fax: 610-717-0668 E-mail: kevin.lentz@westpharma.com
Preparation date: 30 May 2014
Classification:
Classification Name: Piston Syringe (Accessory) Trade Name: NovaGuard SA Safety System Common/Usual Name: Anti Stick Syringe Product Code: MEG Regulation No.: 21 CFR 880.5860 Class: II Panel Identification: General Hospital Panel
CONFIDENTIAL
4
Predicate Devices:
UltraSafe Passive PLUS Needle Guard (K123743) Safe'n'Sound Passive Delivery System (K101233)
Device Description:
The proposed device, NovaGuard SA Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8" The NovaGuard SA Safety System consist of two components, a subassembly (syringe holder, sleeve and spring) and a clip. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.
Indications for use:
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Substantial equivalence:
Based on the indications for use, technology, design features and principle of operation the proposed device, NovaGuard SA Safety System, is substantially equivalent to the predicate devices, UltraSafe Passive PLUS Needle Guard (K123743) and Safe'n'Sound Passive Delivery System (K101233).
Performance Testing:
Bench testing was performed on the proposed device, NovaGuard SA Safety System. It was confirmed that the device functioned as intended.
Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited (