(99 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the guidewires, with no mention of AI or ML algorithms for image analysis, data processing, or decision support.
No
The device is described as PBN Guidewires, intended for directing a catheter through a blood vessel. Its purpose is to facilitate the placement of other medical devices (catheters), not to provide a therapeutic effect on the body itself.
No
Explanation: The device, PBN Guidewires, is described as being used for "directing the catheter through a blood vessel." This is an interventional or procedural function, not a diagnostic one. Diagnostic devices are typically used to identify or characterize diseases or conditions.
No
The device description clearly states it is a physical guidewire made of stainless steel or nitinol, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel." This describes a device used within the body for a procedural purpose (guiding a catheter), not for examining specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details the physical components and coatings of a guidewire, which is a medical device used in interventional procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Product codes
DQX
Device Description
The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
through a blood vessel
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
The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests. The results of the testing indicated that they are comparable to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/11 description: The image is a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in black and white, with the text "MDTECH" in large, bold letters. Below the text is the phrase "MEDICAL DEVICE TECHNOLOGIES INC" in smaller letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.
600 SW 47th Avenue iainesville, Florida 32608 AUG 1 3 2003
| TEL: 352/338-0440 FAX: 352/338-0662 | ||
|---|---|---|
| 510(k) SUMMARY | ||
| APPLICANT: | Medical Device Technologies, Inc. | |
| 3600 SW 47th Avenue | ||
| Gainesville, FL 32608 | ||
| CONTACT: | Karl Swartz | |
| Quality Assurance Manager | ||
| TELEPHONE: | (352)338-0440 | |
| fax (352)338-0662 | ||
| TRADE NAMES: | PBN Guidewires | |
| COMMON NAME: | Guidewires | |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, CFR 870.1330 | |
| PRODUCT CODE: | DQX | |
| PANEL: | Cardiovascular | |
| SUBSTANTIAL EQUIVALENCE: | ||
| Company Name | Product Name | 510(k) No. |
DESCRIPTION OF DEVICE:
Microvenia Corporation
The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.
Guidewires
INDICATIONS FOR USE:
The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
FUNCTIONAL & SAFETY TESTING:
The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests. The results of the testing indicated that they are comparable to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for MD Tech Medical Device Technologies Inc. The logo is in black and white, with the letters "MD TECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is enclosed in a rectangular box with rounded corners.
`600 SW 47th Avenue iainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
TECHNICAL COMPARISON:
The following attributes of the PBN guidewire were examined and found to be comparable to the predicate device:
- Intended size 1.
-
- Length
- Distal end configuration 3.
- Intended anatomical location of distal end 4.
- ર . Proximal end configuration
- Materials 6.
- Labeling 7.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the people.
Public Health Service
AUG 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Technologies, Inc. c/o Mr. Karl Swartz 3600 S. W. 47th Avenue Gainesville, FL 32608
Re: K031442
PBN Guidewires Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: May 2, 2003 Received: May 19, 2003
Dear Mr. Swartz:
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. Iisting 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.
3
Page 2 - Mr. Karl Swartz
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. 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) 594-4646. 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 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image is a logo for MDTECH Medical Device Technologies INC. The logo is black and white and features the letters "MDTECH" in large, bold font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is rectangular with rounded corners.
7600 SW 47th Avenue Jainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1
510(k) Number (if known):___K 031442
Device Name: PBN Guidewires
Indications for Use:
The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96
MCQTM
510(k) Num