MANAN GWI GUIDE WIRE INTRODUCER

• K Number: K974745
• Device Name: MANAN GWI GUIDE WIRE INTRODUCER
• Manufacturer: MEDICAL DEVICE TECHNOLOGIES, INC.
• Date Cleared: 1998-04-06 ( 108 days)
• Product Code: DRC
• Regulation Number: 870.1390
• Type: Traditional
• Panel: Cardiovascular
• Age Range: All
• Reference & Predicate Devices: K851834
• Predicate For: N/A

Intended Use

The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.

Device Description

This introducer is made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths. The tip of the introducer is ground to a chisel bevel. it differs from a standard "CHIBA" needle only in the hub. The Guide Wire Introducer's hub has a funnel shaped interior configuration to facilitate introduction of the guidewire.

AI/ML Overview

The provided documentation does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria. This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device, the Manan Medical Products Guide Wire Introducer (K851834), rather than presenting detailed performance study data against defined acceptance criteria.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

The document states that the Manan™ Guide Wire Introducer is "made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths" and that "The tip of the introducer is ground to a chisel bevel." It also highlights a key differentiating feature: "The Guide Wire Introducer's hub has a funnel shaped interior configuration to facilitate introduction of the guidewire." These are descriptive features rather than performance metrics with associated acceptance criteria. The FDA's decision letter confirms that the device is "substantially equivalent" to the predicate device, implying that its performance characteristics are deemed comparable without requiring a new, detailed performance study in this context.

Summary

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KA74745

Image /page/0/Picture/1 description: The image shows the logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters MDTECH in a stylized font. The words MEDICAL DEVICE TECHNOLOGIES INC are written below the letters MDTECH. The logo is simple and modern.

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

APR - 6 1998

510(k) SUMMARY

APPLICANT:	Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608
CONTACT:	Karl SwartzQuality Assurance Manager
TELEPHONE:	[phone]fax [phone]
TRADE NAMES:	Manan™ Guide Wire Introducer
COMMON NAME:	Guide wire introducer
CLASSIFICATION NAME:	Introducer, Percutaneous - 74DYR
SUBSTANTIAL EQUIVALENCE:
Company Name	Product Name	510(k) No.
Manan Medical Products	Guide Wire Introducer	K851834

DESCRIPTION OF DEVICE:

This introducer is made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths. The tip of the introducer is ground to a chisel bevel. it differs from a standard "CHIBA" needle only in the hub. The Guide Wire Introducer's hub has a funnel shaped interior configuration to facilitate introduction of the guidewire.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by a serpent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 1998

Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainsville, FL 32608

K974742, K974743 and K974745 Re : Manan™ Potts-Cournand Needle, Trade Name: Manan™ Seldinger Needle and Manan™ GWI Guide Wire Introducer Requlatory Class: II Product Code: DRC Dated: March 18, 1998 Received: March 19, 1998

Dear Mr. Swartz:

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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory action. In

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Page 2 - Mr. Karl Swartz

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 obliqation you might have under sections 531 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 begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and ... ....... Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for MDTech Medical Device Technologies Inc. The logo is in black and white, with the letters "MDTECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is simple and professional, and it effectively communicates the company's name and industry.

Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

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510(k) Number (if known): _ _ K97

Device Name: Manan™ Guide Wire Introducer

Indications for Use:

The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra A M

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.