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
1. One stainless steel 0.035" or 0.038" guidewire
1. Five plastic dilators, sized 8, 12, 16, 20 and 24 Fr.
  These pieces may be packaged, sterilized and sold separately.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the ESTECH Percutaneous Dilator Insertion Kit. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, ground truth, and reader studies is not directly applicable or available in this 510(k) summary. This document focuses on demonstrating equivalence through design, materials, intended use, and manufacturing testing.

Here's the breakdown of what is available based on the provided text, and where your requested information is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility in compliance with ISO 10993	Biocompatibility analysis demonstrates that the kit components are in compliance with ISO 10993.
Meets performance specifications through manufacturing inspection and testing	Manufacturing inspection and testing demonstrate that the kit meets its performance specifications.
Substantially equivalent to predicate device (Maxxim Medical Vessel Dilator K963388) in intended use, design, materials, packaging, and sterilization.	"Estech concludes that the devices are substantially equivalent." The FDA agreed with this conclusion, stating "the device is substantially equivalent to legally marketed predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided. This 510(k) does not present data from a clinical "test set" in the sense of patient data for diagnostic performance. The "testing" mentioned refers to manufacturing inspection and biocompatibility analysis.

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)

Not Applicable/Not Provided. No ground truth for a diagnostic test set was established as no such study was conducted or required for this type of device and submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Provided. No test set or adjudication for diagnostic performance was performed.

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

Not Applicable/Not Provided. This device is a physical medical instrument (vessel dilator), not an AI/diagnostic software. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Provided. This device is a physical medical instrument, not an algorithm. Standalone performance as typically described for AI is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Not Provided. No clinical ground truth was established for "diagnostic" performance. The "ground truth" for the device's acceptable performance is its compliance with established standards (ISO 10993 for biocompatibility) and its ability to meet engineering specifications through manufacturing tests.

8. The sample size for the training set

Not Applicable/Not Provided. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable/Not Provided. There is no training set for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in this 510(k) is essentially a bench testing and biocompatibility analysis rather than a clinical trial or diagnostic performance study.

Biocompatibility Analysis: The kit components underwent biocompatibility analysis to demonstrate compliance with ISO 10993. This standard assesses the biological response of medical devices in contact with the human body. The results showed compliance.
Manufacturing Inspection and Testing: The device components were subjected to manufacturing inspections and various performance tests to ensure they met their predetermined engineering and performance specifications. The details of these specific tests (e.g., tensile strength, dimensional accuracy, ease of use, etc.) are not elaborated upon in this summary but are implied by the statement "Manufacturing inspection and testing demonstrate that the kit meets its performance specifications."

The ultimate proof of the device meeting its acceptance criteria, particularly for a 510(k) submission, is the demonstration of substantial equivalence to a previously legally marketed predicate device (Maxxim Medical Vessel Dilator, K963388). This equivalence is based on:
* Identical intended use.
* Similar design principles (minor differences in hub and range of diameters were deemed not to raise new safety/efficacy concerns).
* Similar materials.
* Similar packaging and sterilization methods (sterile, single-use, ethylene oxide sterilized).

The FDA's decision to clear the device (K070749) confirms that, based on the submitted data, it was found to be substantially equivalent to the predicate device, thereby meeting the regulatory acceptance criteria for market entry under the 510(k) pathway.

Summary

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Section 5: 510(k) Summary

K070749
OCT 24 2007

Device Information:

Category	Comments
Sponsor:	Estech2603 Camino Ramon.Suite 100San Ramon, CA 94583Tel: 925-866-7111
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
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 ArgonMedical Devices
Predicate Device Common Name:	Vessel dilator for percutaneouscatheterization
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

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

These pieces may be packaged, sterilized and sold separately.

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112

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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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150, 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)

	Page 1 of ______
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(Division Sigh-Off)

Division of Cardiovascular Devices

510(k) Number	K070749
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Regulation Number and Section

§ 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).