ESTECH PERCUTANEOUS INSERTION DILATOR KIT

K070749 · Coombs Medical Device Consulting · DRE · Oct 24, 2007 · Cardiovascular

Device Facts

• Record ID: K070749
• Device Name: ESTECH PERCUTANEOUS INSERTION DILATOR KIT
• Applicant: Coombs Medical Device Consulting
• Product Code: DRE · Cardiovascular
• Decision Date: Oct 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.

Device Story

The ESTECH Percutaneous Dilator Insertion Kit is a sterile, single-use physician convenience kit used to dilate blood vessels to facilitate the insertion of large diameter catheters or cannulae. The kit includes an 18-gauge stainless steel insertion needle, a stainless steel 0.035" or 0.038" guidewire, and five plastic dilators (8, 12, 16, 20, and 24 Fr). The device is used by physicians in a surgical setting. By sequentially dilating the vessel opening, the kit enables the safe introduction of large-bore medical devices, benefiting patients by streamlining access procedures.

Clinical Evidence

Bench testing only. Biocompatibility analysis confirms compliance with ISO 10993. Manufacturing inspection and performance testing demonstrate the kit meets specifications.

Technological Characteristics

Kit components include stainless steel needle and guidewire, and plastic dilators (8-24 Fr). Single-use, ethylene oxide sterilized. No electronic or software components.

Indications for Use

Indicated for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula in patients requiring large diameter catheter access.

Regulatory Classification

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.

Predicate Devices

• Vessel Dilators (K963388)

Submission Summary (Full Text)

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# Section 5: 510(k) Summary

K070749
OCT 24 2007

Device Information:

| Category | Comments |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Estech<br>2603 Camino Ramon.<br>Suite 100<br>San Ramon, CA 94583<br>Tel: [phone] |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Vessel Dilators |
| Device Classification & Code: | Class II, DRE (21 CFR 870.1310) |
| Device Classification Name: | Vessel dilator for percutaneous catheterization |
| Device Proprietary Name: | ESTECH Percutaneous Dilator Insertion Kit |

#### Predicate Device Information:

| Predicate Devices: | Vessel Dilators (K963388) |
|-----------------------------------------|-------------------------------------------------------------|
| Predicate Device Manufacturers: | Maxxim Medical, Inc. a division of Argon<br>Medical Devices |
| Predicate Device Common Name: | Vessel dilator for percutaneous<br>catheterization |
| Predicate Device Classification: | 21 CFR 870.1310 |
| Predicate Device Classification & Code: | Class II, DRE |

#### b. Date Summary Prepared

9 March 2007

## c. Description of Device

The Estech Percutaneous Dilator Insertion Kit is a sterile, single-use, physicians convenience kit to dilate blood vessels to allow for the insertion of large diameter catheters. The kit consists of seven pieces:

- 1. One 18 gage stainless steel insertion needle
- 2. One stainless steel 0.035" or 0.038" guidewire
- 3. Five plastic dilators, sized 8, 12, 16, 20 and 24 Fr.

These pieces may be packaged, sterilized and sold separately.

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## d. Intended Use

The ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.

### e. Comparison to Predicate Device

The Estech Percutaneous Insertion Dilator is substantially equivalent in intended use, design, materials, packaging and sterilization to the Maxxim Medical Vessel Dilator (K963388).

Both devices enlarge the opening in a blood vessel to permit the introduction of large diameter catheters or cannulae

The only differences between the predicate and the application device are that the predicate has a proximal hub that can be locked into the hub of some introducers and they have a different range of outside diameters. These design differences are not technological differences. These design differences do not introduce new issues of safety or efficacy.

Both devices are single use only and ethylene oxide sterilized.

Estech concludes that the devices are substantially equivalent.

## f. Summary of Supporting Data

Biocompatibility analysis demonstrates that the kit components are in compliance with ISO 10993.

Manufacturing inspection and testing demonstrate that the kit meets its performance specifications and is therefore substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, creating a simple and recognizable emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2007

OCT 24 2007

Endoscopic Technologies, Inc. c/o Mr. Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman Street Alameda, CA 94501

Re: K070749

Trade/Device Name: ESTECH Percutaneous Dilator Insertion Kit Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherization Regulatory Class: Class II Product Code: DRE Dated: October 18, 2007 Received: October 12, 2007

Dear Mr. Coombs:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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. Craig Coombs

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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR 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 [phone] or [phone], or at its Internet address http://www.fda.qov/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

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Section 4: Indications for Use Statement

510(k) Number (if known):

K07 0749

ESTECH Percutaneous Dilator Insertion Kit Device Name:

Indications For Use:

The ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

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(Division Sigh-Off)

Division of Cardiovascular Devices

| 510(k) Number | K070749 |
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