ESTECH HAWKEYE INTRODUCER SYSTEMS

K091350 · Endoscopic Technologies, Inc. D/B/A Estech · GCJ · Sep 15, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091350
• Device Name: ESTECH HAWKEYE INTRODUCER SYSTEMS
• Applicant: Endoscopic Technologies, Inc. D/B/A Estech
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

Device Story

Hawkeye Introducer System consists of magnetic cannula assembly, magnetic introducer, and malleable stylet. Used in minimally invasive surgery to provide access for delivery and placement of surgical instruments (e.g., pacing probes). Operates via blunt tissue dissection within thoracic cavity. Single-use device. Physician-operated in clinical/surgical settings. Provides physical pathway for instrument placement; facilitates surgical workflow by enabling access to thoracic structures.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing to verify product specifications, biocompatibility testing per ISO 10993, and animal/cadaver testing to demonstrate functional performance and clinical utility.

Technological Characteristics

Single-use endoscopic accessory system. Components include magnetic cannula, magnetic introducer, and malleable stylet. Biocompatible materials compliant with ISO 10993. Mechanical device for tissue access and instrument delivery.

Indications for Use

Indicated for patients requiring blunt dissection of tissue, including structures in the thoracic space, during minimally invasive surgery.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Flexview System (K062050)

Submission Summary (Full Text)

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SEP 15 2009

91350

SEP End & Opic Technologies, Inc.

ESTECH Hawkeye™ Introducer S Premarket Notification

# SECTION 5: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Information:

| Category | Comments |
|--------------------------|--------------------------------------------------------------------------------------------|
| Sponsor: | ESTECH, Inc.<br>2603 Camino Ramon<br>Suite 100<br>San Ramon, CA 94583<br>Tel: [phone] |
| Correspondent: | Tamer Ibrahim<br>Vice President<br>ESTECH, Inc |
| Contact Information: | Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Endoscope, Accessories |
| Device Proprietary Name: | Hawkeye™ Introducer System |
| Device Classification: | Class II, GCJ (21 CFR 876.1500) |

#### Predicate Device Information:

| Predicate Devices: | Flexview System (K062050) |
|-----------------------------------------|-------------------------------------------------------|
| Predicate Device Manufacturers: | Guidant, followed by Boston Scientific, now<br>Maquet |
| Predicate Device Common Name: | Endoscope, Accessories |
| Predicate Device Classification: | 21 CFR 876.1500 |
| Predicate Device Classification Number: | Class II, GCJ |

#### b. Date Summary Prepared

May 6, 2009

#### c. Description of Device

The Hawkeye family consists of two products; the ESTECH Hawkeye Magnetic Introducer System and the ESTECH Hawkeye Scope System.

The Hawkeye Magnetic Introducer System is comprised of three main components:

- 1. Hawkeye Magnetic Cannula Assembly
- 2. Magnetic Introducer
- 3. Malleable Stylet

Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment.

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Koq 1350

# Endoscopic Technologies. Inc.

These pieces may be packaged, sterilized and sold separately. They are single-use only.

## d. Intended Use

The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

#### e. Comparison to Predicate Device

The Hawkeye™ Introducer System is substantially equivalent in intended use, technology, design and materials to the Guidant FLEXView System (K062050).

ESTECH concludes that the devices are substantially equivalent.

## f. Summary of Supporting Data

Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993

Bench testing has demonstrated that the device meets the proposed product specifications.

Animal testing and cadaver testing demonstrated that the device can be used as intended and will meet the expectations of the medical community.

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SEP 1 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Estech, Inc. % Tamer Ibrahim VP. R&D. RA. OA 2603 Camino Ramon, Suite 100 San Ramon, California 94583

Re: K091350

Trade/Device Name: Hawkeye™ Introducer Systems™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 26, 2009 Received: August 28, 2009

Dear Tamer Ibrahim:

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. Ilisting 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 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 vour 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Tamer Ibrahim

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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

incerely yours,

fol Pete

ork N. Melleman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Endoscopic Technologies, Inc.

## Section 4: Indications for Use

1091350

510(k) Number (if known):

Device Name: Hawkeye™ Introducer Systems™

Indications For Use:

The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

Prescription Use X

## AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

510(k) Number.

(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)

CONFIDENTIAL

Neil R. Oden for mam
(Division Sign-Off)

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Division of Surgical, Orthopedic, and Restorative Devices

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