(279 days)
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.
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 (polyethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.
The provided text is a 510(k) summary for the Medcomp Vessel Dilator, a medical device for percutaneous entry into a vessel to enlarge the opening for catheter placement. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study involving AI.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable or present in this document.
However, I can extract information related to the bench/performance data/non-clinical testing that demonstrates the device's substantial equivalence to its predicate and reference devices.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a table format with corresponding reported performance values for an AI device. Instead, it states that "The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols." It also mentions "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 data mentioned includes:
- Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires)
- Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters - part 1: general requirements) - described as "Bench Testing"
- Compliance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices -- Part 1: evaluation and testing within a risk management process) - described as "Biocompatibility"
- Compliance with ISO 11135:2014 (Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices) - described as "Sterility"
- Compliance with AAMI / ANSI / ISO 10993-7:2008(R) 2012 (Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals) - described as "Sterility"
- Compliance with ISO 14971:2007 (Medical devices - application of risk management to medical devices)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical performance testing and biocompatibility studies, not a test set related to AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document is not about an AI device or a study requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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
This information is not applicable. The document is about a physical medical device (vessel dilator) and its substantial equivalence, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be the established specifications and requirements outlined in the referenced ISO standards and internal test protocols. For biocompatibility, it's the biological response against predefined safety limits. This isn't "ground truth" in the context of an AI diagnostic device.
8. The sample size for the training set
This information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable.
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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.
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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
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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 DriveHarleysville, PA 19438Tel: (215) 256-4201, x 2285Fax: (215) 256-9191 | |
| Registration Number: | 2518902 | |
| Contact: | Courtney NixCnix@Medcompnet.comRegulatory Affairs Manager: NorthAmerica 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 PercutaneousCatheterization | |
| Product Code: | DRE | |
| Regulation Description: | Vessel Dilator for percutaneouscatheterization | |
| C.F.R. Section: | 21 CFR 870.1310 | |
| Class: | II | |
| Regulation MedicalSpecialty and ReviewPanel: | 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
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Medcomp®: Vessel Dilator
| Device: | Dilator, Vessel for PercutaneousCatheterization |
|---|---|
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneouscatheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation MedicalSpecialty and ReviewPanel: | Cardiovascular |
| Reference Device Information: | |
| 510(k) Number: | Preamendment Device, Device ListingNumber D012540 |
| 510(k) Holder: | Cook® Incorporated |
| Trade Name: | Dilator |
| Common/Usual Name: | Dilator |
| Device: | Dilator, Vessel for PercutaneousCatheterization |
| Product Code: | DRE |
| Regulation Description: | Vessel Dilator for percutaneouscatheterization |
| C.F.R Section: | 21 CFR 870.1310 |
| Class: | II |
| Regulation MedicalSpecialty and ReviewPanel: | 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
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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® DilatorPreamendment(Reference) | Merit® MedicalPercutaneousVessel DilatorK801113(Predicate) | SubstantiallyEquivalentComparison |
|---|---|---|---|---|
| Design | French SizeRanges: 4F-24F | French SizeRanges: 3F-24F | French SizeRanges: 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" |
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Medcomp®: Vessel Dilator
1499 Delp Drive
Tel: 215-256-4201 Fax. 215-256-1787
Harleysville, PA 19438
| Indicationsfor Use | The Medcompvessel dilatorsare designed forpercutaneousentry into avessel in orderto enlarge theopening of thevessel for theplacement of acatheter in avein or artery. | LegallyMarketed | The Merit®Medical vesseldilators aredesigned forpercutaneousentry into avessel utilizingthe Seldingertechnique in orderto enlarge theopening of thevessel for theplacement of acatheter in a veinor artery. | Equivalent toPredicate Devic |
|---|---|---|---|---|
| Sterilization | EO | EO | Legally Marketed | Equivalent |
| Materials | PolyethyleneTubePolypropyleneTube | LegallyMarketed | 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)
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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.
§ 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).