(131 days)
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No
The document describes a mechanical introducer system for minimally invasive surgery and does not mention any AI or ML components or functionalities.
No
A therapeutic device is one that treats or alleviates a disease or condition. This device is an introducer system used to access the thoracic space for other surgical instruments, not to treat a condition itself.
No
The device is described as an introducer system for surgical instruments and an endoscopy system for visualization and blunt dissection, not for diagnosing conditions.
No
The device description clearly outlines physical components (Cannula Assembly, Magnetic Introducer, Malleable Stylet) and mentions bench testing, animal testing, and cadaver testing, all indicative of a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "minimally invasive surgery allowing access for delivery and placement of surgical instruments" and "blunt dissection of tissue". This describes a surgical tool used in vivo (within the body) for a procedural purpose.
- Device Description: The description details components like cannulas, introducers, and stylets, which are typical surgical instruments. It also mentions endoscopic visualization within the thoracic cavity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are typically used for testing samples to detect diseases, conditions, or markers.
Therefore, the Hawkeye™ Introducer Systems are surgical devices, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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:
-
- Hawkeye Magnetic Cannula Assembly
-
- Magnetic Introducer
-
- Malleable Stylet
Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment. These pieces may be packaged, sterilized and sold separately. They are single-use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic space
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows a black and white abstract shape. The shape is mostly black, with some white areas around the edges. The shape appears to be somewhat irregular and organic. It is difficult to determine what the shape represents without more context.
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. |
| 2603 Camino Ramon | |
| Suite 100 | |
| San Ramon, CA 94583 | |
| Tel: 925-543-2110 | |
| Correspondent: | Tamer Ibrahim |
| Vice President | |
| ESTECH, Inc | |
| Contact Information: | Tel: 925-543-2110 |
| Fax: 925-866-7117 | |
| 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 |
| 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:
-
- Hawkeye Magnetic Cannula Assembly
-
- Magnetic Introducer
-
- Malleable Stylet
Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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
3
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 (800) 638-2041 or (240) 276-3150 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
4
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)
Page 1 of
Division of Surgical, Orthopedic, and Restorative Devices
Section 4, Page 1