(21 days)
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.
The provided text describes a 510(k) premarket notification for the VascuPuncture™ PICC Guidewire with Hydro-Silk Coating. This is a medical device submission seeking clearance to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.
The study presented here is a substantial equivalence comparison, not a clinical study designed to test diagnostic or treatment efficacy. Therefore, many of the typical acceptance criteria and study design elements found in a clinical study (like multi-reader multi-case studies, ground truth establishment for a test set of patient data, training set information, etc.) are not applicable in this context.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Justification |
|---|---|---|
| Technological Characteristics | Functional design | The device is substantially equivalent to the predicate device in terms of functional design. (Implied: The functional design of the new device is the same or very similar to the predicate, with the addition of the Hydro-Silk coating). |
| Principles of operation | The device is substantially equivalent to the predicate device in terms of principles of operation. (Implied: It operates on the same basic mechanism as the predicate). | |
| Performance characteristics | Functional and performance characteristics are "demonstrated through equivalence with the predicate device and testing of representative device samples." (Explicit testing was performed; the results of this testing led to the conclusion of substantial equivalence). The specific performance metrics (e.g., tensile strength, lubricity enhancement due to coating) are not detailed but are implied to meet the standards set by the predicate and internal testing. | |
| Material/Biocompatibility | Biocompatibility (with the addition of Hydro-Silk coating) | "Biocompatibility is demonstrated through equivalence with legally marketed predicate devices and the result of biocompatibility testing." (Implied: Biocompatibility testing was conducted on the new coating/device, and the results confirmed its safety for human contact, likely meeting ISO 10993 standards or similar). The predicate also sets a benchmark for biocompatibility. |
| Indications for Use | Maintain the same indications for use as the predicate device. | "The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature." This matches the predicate's indications. |
| Substantial Equivalence | The device does not raise new questions of safety and effectiveness compared to the predicate device. | The conclusion is that the device "is substantially equivalent to the VascuPuncture™ PICC Guidewire" because "this device is substantially equivalent to the predicate device in terms of functional design, indications for use, principles of operation and performance characteristics." The FDA concurred with this determination. |
2. Sample Size Used for the Test Set and the Data Provenance
For a 510(k) submission like this, the "test set" typically refers to the physical devices manufactured and subjected to bench testing or material characterization. It does not refer to patient-level data.
- Sample Size for Bench/Performance Testing: The document states "testing of representative device samples." The exact number is not specified in the provided text.
- Data Provenance: The data comes from internal testing conducted by NeoMetrics, Inc. The location of the testing is not specified, but it would have been performed by the manufacturer or a contract laboratory. This is retrospective in the sense that the test results are generated for the purpose of the submission after product development. It is not patient data, so "country of origin of the data" in a clinical sense is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of submission. "Ground truth" in the context of patient data adjudicated by experts is not relevant here. The "ground truth" for demonstrating substantial equivalence rests on objective engineering and scientific testing to prove that the device performs as intended and is safe, similar to the predicate. The FDA (specifically the Division of Cardiovascular Devices) evaluates the submitted data to determine if substantial equivalence has been met.
4. Adjudication Method for the Test Set
Not applicable in the sense of expert adjudication of clinical outcomes or images. The "adjudication" for this submission is the FDA's review process, where their experts evaluate the provided test data and comparisons to the predicate to determine substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices where human readers interpret patient data (e.g., radiology images). This submission is for a guidewire, a physical interventional device, and the clearance is based on substantial equivalence to an existing device, not on comparative clinical effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a physical medical device (a guidewire), not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Objective Engineering Standards and Bench Test Results: Performance characteristics (e.g., lubricity, tensile strength, kink resistance, coating integrity) are measured against established engineering standards and specifications.
- Biocompatibility Testing Results: Data from tests conducted according to recognized standards (e.g., ISO 10993 series) to confirm the new material's safety in contact with the body.
- Comparison to the Predicate Device: The established performance and safety profile of the legally marketed predicate device (VascuPuncture PICC Guidewire, K031652) serves as the primary benchmark.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this type of physical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a mechanical device, there is no training set for an algorithm described in this submission.
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VascuPuncture™ PICC Guidewire with Hydro-Silk Coating NeoMetrics, Inc.
APR 1 9 2004
Appendix G
510(k) Summary
| Submitter: | NeoMetrics, Inc.14800 28th Ave. N., Suite 150Plymouth, MN 55447 |
|---|---|
| Contact Person: | Gene ChampeauPresident763-559-4440 (voice)763-559-7676 (fax) |
| Date Prepared: | March XX, 2004 |
| Trade Name: | VascuPuncture™ PICC Guidewire with Hydro-Silk Coating |
| Classification Nameand Number: | Wire, Guide, Catheter: 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate DeviceName and 510(k)Number | VascuPuncture PICC Guidewire, K031652, dated September 30, 2003. |
| Device Description: | DEVICE DESCRIPTIONThe VascuPuncture™ PICC Guidewires are guidewiresconstructed of stainless steel and nickel titanium alloy with alubricious coating. Devices are available in diameters of 0.014and 0.018 inches and in lengths ranging from 45 to 145 cm. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated forpercutaneous entry of peripheral vessels using the SeldingerTechnique. VascuPuncture Guidewires are not indicated for usein the coronary or cerebral vasculature. |
| Statement ofTechnologicalComparison | Functional and performance characteristics are demonstratedthrough equivalence with the predicate device and testing ofrepresentative device samples.Biocompatibility is demonstrated through equivalence withlegally marketed predicate devices and the result ofbiocompatibility testing. |
| Conclusion: | VascuPuncture™ PICC Guidewire with Hydro-Silk Coatingis substantially equivalent to the VascuPuncture™ PICCGuidewire. This conclusion is based upon the fact that thisdevice is substantially equivalent to the predicate device interms of functional design, indications for use, principles ofoperation and performance characteristics. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
NeoMetrics, Inc. c/o Mr. Gene Champeau President 14800 28th Ave. N., Suite 150 Plymouth, MN 55447
Re: K040786
VascuPuncture™ PICC Guidewire with Hydro-Silk Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: March 24, 2004 Received: March 29, 2004
Dear Mr. Champeau:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in to May 28, 1976, the enactment cate of the Medical Device Amendments, or to conimer of the to 112) 2012-12-12 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter rece (10c) that the device, subject to the general controls provisions of the Act. The I va may, are every maxes 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.
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Page 2 -- Mr. Gene Champeau
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) 594-4648. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Omer R. Vachner
( 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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Indications for Use
510(k) Number (if known):_K040786
Vascu Puncture PICC Guidewire with Hydro-Silk Coating Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ina R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
· ~ ~ Number_ K640 786
Page 1 of __ l __
§ 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.