(100 days)
Terumo Neolus Needle, Medtronic Disposable Hypodermic Needle Electrode, MINIRAD Light Saber Introducer Needle, Manan Blunt Needle
Not Found
No
The device description and intended use are for a simple mechanical introducer needle, with no mention of AI/ML terms or functionalities.
No
The device is described as an introducer needle for placement of guidewires, which are diagnostic or interventional tools, not a device that directly provides therapy itself. Its function is to facilitate the use of other devices.
No
The device, a guidewire introducer needle, is intended for the introduction and placement of guidewires in vascular procedures, which is an interventional function rather than a diagnostic one.
No
The device description clearly states it is a physical needle made of stainless steel and plastic, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous introduction and placement of guidewires in vascular procedures." This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The description of the device as a "stainless steel cannula with an attached plastic luer lock hub" is consistent with a medical device used for accessing the body, not for performing a diagnostic test on a sample.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating the placement of a guidewire within the vascular system.
N/A
Intended Use / Indications for Use
The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
Product codes
GDF
Device Description
The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk .
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)
Terumo Neolus Needle, Medtronic Disposable Hypodermic Needle Electrode, MINIRAD Light Saber Introducer Needle, Manan Blunt Needle
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 031173
510 (k) SUMMARY
1. Submitter's Name / Address:
NeedleTech Products, Inc. 81 West Street Attleboro, MA 02703 Telephone: 508-431-4000 · FAX: 508-431-2156 rtripp@needletech.com e-Mail:
Contact Person: Rick Tripp Product Assurance Manager Submission Date: May 5, 2002
2. Device Name:
NeedleTech Guidewire Introducer Needle Trade Name: Common Name: Percutaneous Introducer Needle
3. Predicate Devices: Terumo Neolus Needle
Medtronic Disposable Hypodermic Needle Electrode MINIRAD Light Saber Introducer Needle Manan Blunt Needle
4. Device Description:
The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk .
5. Intended Use:
The guidewire introducer needles are intended to be single-use disposable introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
6. Substantial Equivalence:
The NeedleTech Guidewire Introducer Needle is substantially equivalent to a combination of its predicate devices, with the exception of minor differences in size and general indications for use, which raise no new issues regarding safety of effectiveness.
1
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 depiction of an eagle or bird with three curved lines forming its body and head. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2003
Mr. Rick Tripp Product Assurance Manager NeedleTech Products, Inc. 81 West Street Attleboro, Massachusetts 02703
Re: K031173
Trade/Device Name: NeedleTech Guidewire Introducer Needle Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: GDF Dated: April 11, 2003 Received: May 8, 2003
Dear Mr. Tripp:
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.
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Page 2 - Mr. Rick Tripp
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 (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
C. Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications For Use
510K Number (if known): _ KO31173
Device Name: NeedleTech Guidewire Introducer Needle
Indications For Use:
The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031173
(Optional Format 3-10-98)
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