(119 days)
The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.
The Alligator™-HD Retrieval Device (ARD-HD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with an off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD-HD device are made of radio opaque material facilitating fluoroscopic visualization. The ARD-HD is for single use only.
The provided text is a 510(k) summary for the Alligator™-HD Retrieval Device. It is a submission for a medical device to demonstrate substantial equivalence to a legally marketed predicate device, not a clinical study report of a new device's performance against detailed acceptance criteria.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for a test set, data provenance, or ground truth establishment for a diagnostic algorithm.
- Information on expert panels (number, qualifications, adjudication methods) for establishing ground truth.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample size for training sets or how their ground truth was established.
The document focuses on demonstrating substantial equivalence to predicate devices based on design, function, manufacturing, materials, indications, packaging, sterilization, and labeling. It explicitly states that "The information presented in the 510k shows that the Alligator™-HD Retrieval Device, ARD-HD is substantially equivalent to predicate endovascular snare devices in regards to the following aspects."
This type of submission typically relies on non-clinical performance data (e.g., bench testing, biocompatibility, sterilization validation) to support the safety and effectiveness claims, rather than clinical efficacy studies with human subjects and diagnostic performance metrics like sensitivity, specificity, or reader improvement.
In summary, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it argues for substantial equivalence to existing devices.
{0}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)
Submitted by:
Chestnut Medical Technologies, Inc. 173 Jefferson Drive Menlo Park, CA 94025 Tel .: (650) 566-8953 Fax: (650) 566-0072
APR 2 2 2010
ું
ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
Contact Person: Daniel Cher, M.D.
Date summary prepared: December 11, 2009
Trade Name: Alligator™-HD Retrieval Device, ARD-HD
Common Name: Endovascular snare device
Classification Name: Catheter, Percutaneous (21 CFR 870.1250, Product Code DOY)
Device Description:
The Alligator™-HD Retrieval Device (ARD-HD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with an off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD-HD device are made of radio opaque material facilitating fluoroscopic visualization. The ARD-HD is for single use only.
Indications for Use:
The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.
Predicate Device: Alligator™ Retrieval Device; 510k # K043580, Boston Scientific, Target In-Time Retrieval Device; 510k# K014109, Microvena Corp. Amplatz Microsnare, 510k# K970668
Comparison to Predicate Devices to Support Substantial Equivalence Determination:
The information presented in the 510k shows that the Alligator™-HD Retrieval Device, ARD-HD is substantially equivalent to predicate endovascular snare devices in regards to the following aspects:
{1}------------------------------------------------
| Design: | The subject (Alligator™-HD Retrieval Device, ARD-HD) andpredicate device (Alligator™ Retrieval Device; 510k # K043580)are substantially equivalent with respect to design andtechnological characteristics. Both are made of similar materialsand fabricated using the same manufacturing procedures. |
|---|---|
| Function: | The subject and predicate devices are substantially equivalent withrespect to functional characteristics. The subjective device will beprovided with shorter lengths and one size larger size jaw for thecardiovascular indication. |
| Manufacturing: | The subject and predicate devices are similar with respect totechnological manufacturing processes. |
| Materials: | The subject and predicate devices are composed of identicalmaterial composition, all of which have an extensive clinicalhistory of safe use in medical devices. Although the differences inconstruction and materials are incidental, the ARD-HD was testedfor biocompatibility. |
| Indications: | The subject (Alligator™-HD Retrieval Device, ARD-HD) andpredicate device (Alligator™ Retrieval Device, ARD) aresubstantially equivalent with respect to the indication.The predicate ARD is intended for use in the peripheral andneurovasculature for foreign body retrieval.The subject ARD-HD is intended for use in the peripheral, neuroand cardiovasculature for foreign body retrieval.The cardiovasculature indication was granted to the predicatedevices: Boston Scientific, Target In-Time Retrieval Device;510k# K014109Microvena Corp. Amplatz Microsnare, 510k#K970668 |
| Packaging: | The subject and predicate devices utilize identical packagingconfigurations. |
| Sterilization: | The subject and predicate devices are both sterilized utilizing anEthylene Oxide sterilization cycle validated in accordance withISO 11135 - Medical Devices - Validation and Routine Control ofEthylene Oxide Sterilization. |
| Labeling: | Both the subject and predicate devices have similar labeling. |
Alligator™-HD Retrieval Device Page 12 of 65
:"
・
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. To the right of the eagle is the word "DEPARTMENT" in a sans-serif font. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 2 2010
Chestnut Medical Technologies, Inc. c/o Dr. Daniel Cher VP of Clinical and Regulatory Affairs 173 Jefferson Drive Menlo Park, CA 94025
Re: K093977
Trade/Device Name: Alligator™-HD Retrieval Device, ARD-HD Common Name: Endovascular snare device, Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DOY Dated: April 5, 2010 Received: April 7, 2010
Dear Dr. Cher:
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
{3}------------------------------------------------
Page 2 - Dr. Daniel Cher
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 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.htm 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): To be assigned KjAj4 1 1
Device Name: Alligator™-HD Retrieval Device
Indications for Use:
The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
assamed to the result of the company of the comments of the production and manufactures and manufacturer and manufacturer and manufacturer and manufacturer and manufacturer a
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
Number 1093977
Page 1 of 1
Alligator™-HD Retrieval Device
Page 9 of 65
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).