(226 days)
Not Found
No
The description focuses on a mechanical safety mechanism for a guidewire introducer and does not mention any computational or learning capabilities.
No
The device is described as a percutaneous guide wire introducer, a tool for accessing vessels or other areas, and its primary function as described is for safe introduction of a guide wire and prevention of needle stick injuries. This indicates it is an accessory device used for a procedure, not a device that directly treats a disease or condition.
No
The device is described as a percutaneous guide wire introducer, used for introducing a guide wire for vascular and non-vascular procedures. Its function is to facilitate entry, not to diagnose a condition.
No
The device description clearly describes a physical needle and hub device with a safety shield, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states it's a "percutaneous guide wire introducer for vascular and non-vascular procedures." This indicates a device used in vivo (within the body) for a medical procedure, not for testing samples in vitro (outside the body).
- Device Description: The description details a "needle and hub device for the percutaneous introduction of a guide wire." This further reinforces its use in a medical procedure on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating the introduction of a guide wire into the body.
N/A
Intended Use / Indications for Use
A percutaneous guidewire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
Product codes (comma separated list FDA assigned to the subject device)
MDM
Device Description
A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
SafetyNET Guidewire Introducer (K040029), Light Saber Introducer Needle (K013040)
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
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
p. (of)
Premarket Notification
SafetyNET Guidewire Introducer
InjectiMed Inc
Ventura, CA
VIII. Premarket Notification 510(k) Summary
| Submitted by: | InjectiMed Inc
2737 Palma Drive
Ventura, CA 93003 | AUG - 8 2008 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact person: | Thomas C. Kuracina
President | |
| Date prepared: | December 20, 2007 | |
| Device proprietary name: | SafetyNET Guidewire Introducer | |
| Common name: | Percutaneous Guidewire Introducer | |
| Classification name: | Manual surgical instrument for general use
21 CFR Sec. 878.4800 | |
| Predicate devices: | SafetyNET Guidewire Introducer (K040029) | |
| | Light Saber Introducer Needle (K013040) | |
| Description of the device: | A needle and hub device for the percutaneous
introduction of a guide wire, with a hub modification
to allow one-handed activation of a sheath to cover
the needle and help prevent accidental needle sticks
during use and disposal. | |
| Intended use: | A percutaneous guidewire introducer for vascular
and non-vascular procedures with activating safety
shield to reduce needle stick injury during use and
disposal. | |
| Characteristics: | Sterile, single-use, disposable stainless steel needle
with modified polycarbonate hub/spring assembly | |
| Testing | Product and materials meet all applicable test
requirement per ISO 10993-1 | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top of the emblem. The caduceus is depicted with a triple-stranded design, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
InjectiMed, Inc. % Washington Regulatory Consultants Mr. Richard Hunter, MS, RAC 5616 Mariola Place, NE Albuquerque, New Mexico 87111
AUG - 8 2008
Re: K073664
Trade/Device Name: SafetyNET Guidewire Introducer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: MDM Dated: July 7, 2008 Received: July 10, 2008
Dear Mr. Hunter:
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 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.
2
Page 2 Mr. Richard Hunter, MS, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image contains a series of black shapes against a white background. The shapes appear to be punctuation marks or symbols, possibly including a period, a lowercase "l", and a colon. The symbols are arranged horizontally across the image. The image is simple and lacks any complex details.
Premarket Notification SafetyNET Guidewire Introducer
InjectiMed Inc Ventura, CA
V. Indications for Use Statement
510(k) Number:
To be assigned
Device Name:
SafetyNET Guidewire Introducer
Indications for Use:
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart )
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 16073664