ProteXsure Safety Capsule System
Device Facts
| Record ID | K152597 |
|---|---|
| Device Name | ProteXsure Safety Capsule System |
| Applicant | Starcap Medical, LLC ( Dba Prism Medical & Design) |
| Product Code | FMI · General Hospital |
| Decision Date | Jun 8, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Indications for Use
The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles. This device should only be used when a biohazard Sharps Container is not readily available.
Device Story
ProteXsure Safety Capsule System is a single-use, passive needle protection device; designed to cover needle tips post-injection to prevent accidental needle sticks. Used by clinicians or patients when biohazard sharps containers are not immediately accessible. Device acts as a temporary safety sheath for 25G to 31G needles. Benefit includes reduced risk of percutaneous injury in settings where immediate sharps disposal is unavailable.
Clinical Evidence
Bench testing only.
Technological Characteristics
Single-use needle protection device; compatible with 25G-31G needles; mechanical sheath design; non-powered.
Indications for Use
Indicated for use as a single-use needle protection device for 25G to 31G needles to minimize needle stick risk when a biohazard sharps container is unavailable.
Regulatory Classification
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.
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2016
StarCap Medical, LLC (DBA Prism Medical & Design) c/o Mr. Matt Hedlund 510k Consultant 3924 North East 157th Place Lake Forest Park, Washington 98155
Re: K152597
Trade/Device Name: ProteXsure Safety Capsule System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: May 5, 2016 Received: May 11, 2016
Dear Mr. Hedlund:
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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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 (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.
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,
Tina
Kiang -S
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
Enclosure
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## Indications for Use
510(k) Number (if known) K152597
Device Name ProteXsure Safety Capsule System
## Indications for Use (Describe)
The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles. This device should only be used when a biohazard Sharps Container is not readily available.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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