(99 days)
The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
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.
The provided text describes the PBN Guidewires and their substantial equivalence to a predicate device, focusing on functional and safety testing as well as technical comparison. However, it does not include specific acceptance criteria or an in-depth study report with detailed performance metrics, sample sizes for test sets, ground truth establishment, or human reader studies.
Based on the provided information, I can only extract limited details regarding acceptance criteria and the "study" (which is referred to as "Functional & Safety Testing" and "Technical Comparison").
Here's a breakdown of what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Tensile Strength (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Torqueability (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Tip Flexibility (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Coating Adherence/Integrity (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Intended Size (Comparable to predicate) | Found to be comparable to the predicate device. |
| Length (Comparable to predicate) | Found to be comparable to the predicate device. |
| Distal End Configuration (Comparable to predicate) | Found to be comparable to the predicate device. |
| Intended Anatomical Location of Distal End (Comparable to predicate) | Found to be comparable to the predicate device. |
| Proximal End Configuration (Comparable to predicate) | Found to be comparable to the predicate device. |
| Materials (Comparable to predicate) | Found to be comparable to the predicate device. |
| Labeling (Comparable to predicate) | Found to be comparable to the predicate device. |
Note: The actual numerical acceptance criteria for "tensile strength," "torqueability," etc., are not provided in the document. The performance is stated as "comparable to the predicate device," which itself serves as the de facto acceptance standard in this 510(k) submission.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests" and "The following attributes of the PBN guidewire were examined," but no number of samples or units tested is provided.
- Data Provenance: Not specified, but generally, such testing for a 510(k) submission would be conducted by the manufacturer (MDTECH Medical Device Technologies, Inc.) or a third-party lab on behalf of the manufacturer, and would be prospective testing of their devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as this submission relates to a medical device's physical and functional properties, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement and comparison to a predicate device.
4. Adjudication method for the test set
- Not applicable. This submission focuses on engineering and performance testing against a predicate device, not on expert consensus or adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a submission for a physical medical device (guidewire), not an AI algorithm or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This device is a guidewire, a physical medical instrument, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for this device's evaluation is the performance and attributes of the identified predicate device (Microvenia Corporation Guidewires, K991898). The PBN Guidewires were determined to be substantially equivalent if their functional and safety characteristics, as well as specified attributes, were "comparable" to the predicate.
8. The sample size for the training set
- Not applicable. This document describes the evaluation of a physical medical device (guidewire), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
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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 AvenueGainesville, FL 32608 | |
| CONTACT: | Karl SwartzQuality Assurance Manager | |
| TELEPHONE: | (352)338-0440fax (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.
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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.
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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.
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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
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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
§ 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.