(275 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML capabilities.
No.
The device facilitates the placement of other medical devices and does not directly treat a disease or condition.
No
Explanation: The device is a guidewire, which is used to facilitate the placement of other medical devices. It does not diagnose medical conditions.
No
The device description clearly details a physical guidewire made of stainless steel with a coiled tip and optional coatings. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the Medcomp .010" Vascular Guidewires are used intravascularly (inside the blood vessels) to facilitate the placement of other medical devices. This is an in vivo (inside the body) application.
- No Mention of Specimen Testing: The document does not mention any testing of biological specimens or providing diagnostic information based on such testing.
The device is a medical device used for interventional procedures within the body, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy.
This device is not intended for coronary or cerebrovascular use.
Product codes
DQX
Device Description
The Medcomp .010" Vascular Guidewires are sterile, single-use devices used to facilitate intravascular medical device insertion. The proposed devices will be packaged and labeled as sterile accessories in individual pouches, or as part of kit configurations.
The Medcomp .010" guidewires consist of a stainless steel core wire, which forms the proximal shaft of the guidewire - reducing in size from the proximal to the distal end, with a smooth transition to the coiled floppy distal tip secured to the end of the core.
The .010" Vascular Guidewires have an outside diameter of 0.010" and are available in 45, 80 and 120cm lengths, with coil lengths of 4cm or 9.5cm. The .010" Vascular Guidewires are uncoated, or are available with a hydrophilic coating or a silicone fluid coating. The hydrophilic and silicone coatings reduce friction during use. Radiopacity of the distal coil region facilitates fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular use, including the peripheral vasculature. Not for coronary or cerebrovascular use.
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
Physical testing was performed on the Medcomp .010" Vascular Guidewires following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) to assure design integrity and performance for the intended use.
Biocompatibility testing was conducted in accordance with ISO 10993 to confirm safety of the proposed device materials for use in an externally communicating device with limited indirect blood path contact.
No clinical studies were performed as part of the 510(k) process as the product is comparable to products currently cleared for marketing and can be applied under the substantial equivalence claim.
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
510(k) SUMMARY
MEDCOMP®
A. Submitter Information:
Submitter:
| Contact: | Lisa Weikert |
|---|---|
| Regulatory Specialist | |
| 1499 Delp Drive | |
| Harleysville, PA 19438 | |
| Tel: (215) 256-4201 | |
| Fax: (215) 256-9191 | |
| Date Prepared: | June 20, 2008 |
| Trade Name: | .010" Vascular Guidewires |
| Common Name: | Guidewires |
| Classification Name: | Catheter Guide wire |
| Product Code: | DQX |
| C.F.R. Section: | 21 CFR 870.1330 |
். Predicate Device:
B.
Lake Region Hydrophilic Guidewire (K040825) - Lake Region Medical* Hydrophilic Guidewire (K033758) - Lake Region Medical* Mandrel Guidewires (K011084) - Lake Region Medical* *(formerly Lake Region Manufacturing, Inc.)
D. Device Description:
The Medcomp .010" Vascular Guidewires are sterile, single-use devices used to facilitate intravascular medical device insertion. The proposed devices will be packaged and labeled as sterile accessories in individual pouches, or as part of kit configurations.
The Medcomp .010" guidewires consist of a stainless steel core wire, which forms the proximal shaft of the guidewire - reducing in size from the proximal to the distal end, with a smooth transition to the coiled floppy distal tip secured to the end of the core.
The .010" Vascular Guidewires have an outside diameter of 0.010" and are available in 45, 80 and 120cm lengths, with coil lengths of 4cm or 9.5cm. The .010" Vascular Guidewires are uncoated, or are available with a hydrophilic coating or a silicone fluid coating. The hydrophilic and silicone coatings reduce friction during use. Radiopacity of the distal coil region facilitates fluoroscopic visualization.
E. Intended Use:
The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy.
Medcomp .010" Vascular Guidewire Summary
1
This device is not intended for coronary or cerebrovascular use.
F. Comparison to Predicate Device:
The technological characteristics of the .010" Vascular Guidewire are substantially equivalent to the predicate devices in terms of intended use. general design, functionality, and materials.
G. Performance Data:
Medcomp has determined that no mandatory performance standards have been established for the proposed devices under Section 514 of the Medical Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action.
Physical testing was performed on the Medcomp .010" Vascular Guidewires following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) to assure design integrity and performance for the intended use.
Biocompatibility testing was conducted in accordance with ISO 10993 to confirm safety of the proposed device materials for use in an externally communicating device with limited indirect blood path contact.
H. Conclusion:
The proposed devices are similar to other devices currently on the market. The materials used in construction of the proposed devices are identical to those used in comparable legally-marketed devices and present no unusual or unacceptable risk to the patient. The optional hydrophilic and silicone coating materials and processes used on the proposed device are also used on legally marketed predicate devices.
No clinical studies were performed as part of the 510(k) process as the product is comparable to products currently cleared for marketing and can be applied under the substantial equivalence claim.
2
Image /page/2/Picture/1 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 emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2009
Medical Components Inc. c/o Ms. Lisa Weikert Regulatory Specialist 1499 Delp Drive Harleysville, PA 19438
Re: K081775
Trade/Device Name: Medcomp .010" Vascular Guidewires Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: February 26, 2009 Received: February 17, 2009
Dear Ms. Weikert:
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, 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.
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
3
Page 2 - Ms. Lisa Weikert
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. product radiation control po begin marketing your device as described in your Section 510(k) I has letter will are n Je FDA finding of substantial equivalence of your device to a legally premarked 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to (210) 270 02161 11103 (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-(Moulea Donec responsible other general information on your responsibilities under the Act from 210 - 101: 108 mls. South Casturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
Indications for Use
510(k) Number (if known): K081775
Device Name: Medcomp® .010" Vascular Guidewires
Indications for Use:
The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy.
This device is not intended for coronary or cerebrovascular use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division ardiovati 510[k] Number