(279 days)
Preamendment Device, Device Listing Number D012540
No
The device description and performance studies focus on the physical characteristics and material properties of a vessel dilator, a mechanical tool. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as a vessel dilator designed for percutaneous entry to enlarge an opening for catheter placement, which is an interventional tool, not a therapeutic device.
No
The device is described as a "Vessel Dilator" designed for percutaneous entry to enlarge an opening for catheter placement, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to detect, monitor, or identify a medical condition.
No
The device description clearly indicates it is a physical medical device made of tubing materials and a hub, designed for percutaneous entry and vessel dilation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enlarge the opening of the vessel for the placement of a catheter in a vein or artery." This is a direct surgical/interventional procedure performed on the patient's body.
- Device Description: The description details a physical tool (dilator) used for mechanical manipulation of a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits.
Therefore, the Medcomp® Vessel Dilator is a medical device used for a procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medcomp Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials (polvethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel, vein, artery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment. The performance testing was performed in accordance with the following standards:
- ISO 11070:2014 Sterile single-use intravascular introducers. ● dilators and quidewires
- ISO10555-1 Second edition 2013-07-01, sterile, single-use intravascular catheters - part 1: general requirements. (General Plastic Surgery/General Hospital) (Bench Testing)
- AAMI / ANSI / ISO 10993-1:2009/(R) 2013, biological s evaluation of medical devices -- Part 1: evaluation and testing within a risk management process. (Biocompatibility)
- ISO 11135 Second edition 2014, sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- AAMI / ANSI / ISO 10993-7:2008(R) 2012, biological evaluation e of medical devices - part 7 : ethylene oxide sterilization residuals. (Sterility)
- ISO 14971 Second edition 2007-03-01, medical devices e application of risk management to medical devices. (General I (QS/RM))
Biocompatibility testing was performed on the final, finished, sterile device, Medcomp® Vessel Dilator (proposed) in accordance with ISO 10993-1. The Medcomp® Vessel Dilator (proposed) meets the requirements for limited, less than or equal to 24 hours, contact external communicating device with indirect blood contact. Biocompatibility studies were conducted by a testing facility that is ISO/IEC 17025 certified. GLP studies were conducted in accordance with the U.S. Food and Drug Administration Good Laboratory Practice (GLP) requlations set forth in 21 CFR part 58.
The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, quidance documents, and internal test protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Preamendment Device, Device Listing Number D012540
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/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 a stylized image of three human profiles facing right, with flowing lines above and below the profiles.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2017
Medcomp (Medical Components) Courtney Nix Regulatory Affairs Manager, North America and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K162389
Trade/Device Name: Medcomp Vessel Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: April 20, 2017 Received: April 24, 2017
Dear Courtney Nix:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Fernando Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162389
Device Name Medcomp Vessel Dilator
Indications for Use (Describe)
The Medcomp Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo for MedComp. The logo consists of a pink geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in pink, followed by "COMP." in gray.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Section 6 | 510(k) Summary | |
|---|---|---|
| A. | Submitter Information: | |
| Submitter: | Medcomp® | |
| 1499 Delp Drive | ||
| Harleysville, PA 19438 | ||
| Tel: (215) 256-4201, x 2285 | ||
| Fax: (215) 256-9191 | ||
| Registration Number: | 2518902 | |
| Contact: | Courtney Nix | |
| Cnix@Medcompnet.com | ||
| Regulatory Affairs Manager: North | ||
| America and EU | ||
| Date Prepared: | 08/23/2016 | |
| B. | Proposed or Subject Device Information: | |
| Trade Name: | Medcomp® Vessel Dilator | |
| Common/Usual Name: | Vessel Dilator | |
| Device: | Dilator, Vessel, for Percutaneous | |
| Catheterization | ||
| Product Code: | DRE | |
| Regulation Description: | Vessel Dilator for percutaneous | |
| catheterization | ||
| C.F.R. Section: | 21 CFR 870.1310 | |
| Class: | II | |
| Regulation Medical | ||
| Specialty and Review | ||
| Panel: | Cardiovascular | |
| B. | Predicate Device: | |
| 510(k) Number: | K801113 | |
| 510(k) Holder: | Merit® Medical | |
| Trade Name: | Percutaneous Vessel Dilator | |
| Common/Usual Name: | Dilator |
Section 6: 510K Summary
Medcomp®: Vessel Dilator
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Image /page/4/Picture/0 description: The image shows a logo with a geometric design in red, resembling an abstract house or arrow shape. Below the geometric shape, the word "med" is written in red, followed by "COMP" in gray. The logo appears to be for a company named Medcomp.
1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com
C.
D.
ட்.
Medcomp®: Vessel Dilator
| Device: | Dilator, Vessel for Percutaneous
Catheterization |
|------------------------------------------------------|-------------------------------------------------------|
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneous
catheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation Medical
Specialty and Review
Panel: | Cardiovascular |
| Reference Device Information: | |
| 510(k) Number: | Preamendment Device, Device Listing
Number D012540 |
| 510(k) Holder: | Cook® Incorporated |
| Trade Name: | Dilator |
| Common/Usual Name: | Dilator |
| Device: | Dilator, Vessel for Percutaneous
Catheterization |
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneous
catheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation Medical
Specialty and Review
Panel: | Cardiovascular |
Purpose for Submission:
The purpose of this submission is to obtain 510(k) clearance for a new product line for Medcomp®.
Device Description:
Medcomp®: Vessel Dilator Section 6: 510K Summary
5
Medcomp®: Vessel Dilator
Image /page/5/Picture/1 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in pink, resembling a house or an abstract letter. Below the shape, the word "medCOMP" is written in a lowercase, italicized font, with "med" in pink and "COMP" in a darker shade. The logo appears to be clean and modern, with a focus on simplicity and visual appeal.
1499 Delp Drive Harlevsville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com Indications for Use:
The Medcomp® Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
(polvethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.
Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single
or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials
Intended Use:
G.
H.
The Medcomp® Vessel Dilator is intended for use for short term vascular access for percutaneous catheterization.
1. Comparison to Predicate and Reference Devices:
The Medcomp® Vessel Dilator is substantially equivalent to the predicate device, Merit® Medical Percutaneous Vessel Dilator (K801113), and the reference device, Cook® Dilator, preamendment, in terms of indications for use, intended use, specifications, anatomical location, biocompatibility, performance, and labeling.
The difference between the predicate device. Merit® Medical Percutaneous Vessel Dilator (K801113), and the reference device, Cook® Dilator (Preamendment), and the Medcomp® Vessel Dilator is the additional product offering made from polyethylene.
Table 5.1: 510(K) Summary: Design Comparison Matrix
| Device | Medcomp®
Vessel Dilator
(Proposed) | Cook® Dilator
Preamendment
(Reference) | Merit® Medical
Percutaneous
Vessel Dilator
K801113
(Predicate) | Substantially
Equivalent
Comparison |
|--------|--------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------|
| Design | French Size
Ranges: 4F-24F | French Size
Ranges: 3F-24F | French Size
Ranges: 4F-6F | Equivalent |
| | Lengths: 15cm,
20cm | Lengths: 10cm,
15cm, 20cm | Lengths: 20cm | |
| | Guidewire Sizes:
.025", .035",
.038" | Guidewire Sizes:
.018", .025",
.035", .038" | Guidewire Sizes:
.035", .038" | |
6
Medcomp®: Vessel Dilator
1499 Delp Drive
Tel: 215-256-4201 Fax. 215-256-1787
Harleysville, PA 19438
| Indications
for Use | The Medcomp
vessel dilators
are designed for
percutaneous
entry into a
vessel in order
to enlarge the
opening of the
vessel for the
placement of a
catheter in a
vein or artery. | Legally
Marketed | The Merit®
Medical vessel
dilators are
designed for
percutaneous
entry into a
vessel utilizing
the Seldinger
technique in order
to enlarge the
opening of the
vessel for the
placement of a
catheter in a vein
or artery. | Equivalent to
Predicate Devic |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Sterilization | EO | EO | Legally Marketed | Equivalent |
| Materials | Polyethylene
Tube
Polypropylene
Tube | Legally
Marketed | Polypropylene | Equivalent |
J. Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment. The performance testing was performed in accordance with the following standards:
- ISO 11070:2014 Sterile single-use intravascular introducers. ● dilators and quidewires
- 。 ISO10555-1 Second edition 2013-07-01, sterile, single-use intravascular catheters - part 1: general requirements. (General Plastic Surgery/General Hospital) (Bench Testing)
- AAMI / ANSI / ISO 10993-1:2009/(R) 2013, biological s evaluation of medical devices -- Part 1: evaluation and testing within a risk management process. (Biocompatibility)
- ଦ ISO 11135 Second edition 2014, sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- AAMI / ANSI / ISO 10993-7:2008(R) 2012, biological evaluation e of medical devices - part 7 : ethylene oxide sterilization residuals. (Sterility)
7
Image /page/7/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in red cursive, and the word "COMP" is written in gray block letters.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Vessel Dilator
- ISO 14971 Second edition 2007-03-01, medical devices e application of risk management to medical devices. (General I (QS/RM))
- Biocompatibility:
K.
L
Biocompatibility testing was performed on the final, finished, sterile device, Medcomp® Vessel Dilator (proposed) in accordance with ISO 10993-1. The Medcomp® Vessel Dilator (proposed) meets the requirements for limited, less than or equal to 24 hours, contact external communicating device with indirect blood contact. Biocompatibility studies were conducted by a testing facility that is ISO/IEC 17025 certified. GLP studies were conducted in accordance with the U.S. Food and Drug Administration Good Laboratory Practice (GLP) requlations set forth in 21 CFR part 58.
Summary of Substantial Equivalence:
In conclusion, the Vessel Dilators (proposed device) are substantially equivalent to the predicate (Merit® Medical Percutaneous Vessel Dilator, K801113) and reference device (Cook® Dilator, preamendment). Medcomp®'s Vessel Dilators (proposed device) are substantially equivalent to the reference device (Cook® Dilator, preamendment) in terms of intended use, anatomical location, basic design, performance, and labeling. Medcomp®'s Vessel Dilator (proposed device) are substantially equivalent to the predicate device's (Merit® Medical Percutaneous Vessel Dilator, K801113) instructions for use (labeling).
The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, quidance documents, and internal test protocols. Through testing, the additional product line made from polyethylene material, the proposed device. Vessel Dilators, are substantially equivalent to the indicated legally marketed reference device (Cook® Dilator, preamendment), and predicate device (Merit® Medical Percutaneous Vessel Dilator, K801113) as defined in the paragraph above.