(108 days)
Not Found
No
The description focuses on the mechanical design and intended use of a guide wire introducer, with no mention of AI or ML capabilities.
No
The device is described as an introducer for percutaneous puncture, facilitating the introduction of a guidewire. Its function is to create an entry point, not to treat, diagnose, or mitigate a disease or condition.
No
The device is described as an introducer for a guide wire for arterial puncture, not for diagnosing any condition. Its mechanical description and intended use do not suggest a diagnostic function.
No
The device description clearly indicates it is a physical introducer made of various gauges and lengths, with a ground tip and a specific hub configuration. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "anterior, single wall arterial percutaneous puncture." This describes a procedure performed directly on a patient's body, not on samples taken from the body.
- Device Description: The description details a physical instrument used for puncturing tissue and introducing a guidewire. This is a surgical/interventional device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostics.
This device is a medical device used for a percutaneous procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.
Product codes
DRC
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: 352/338-0440 FAX: 352/338-0662
APR - 6 1998
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.
4445-310 SW 35th Terrace
Gainesville, FL 32608 | |
|--------------------------|----------------------------------------------------------------------------------------|------------|
| CONTACT: | Karl Swartz
Quality Assurance Manager | |
| TELEPHONE: | (352)338-0440
fax (352)338-0662 | |
| 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.
1
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 (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 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: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
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)