← Product Code [KTI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI) · K020765 # MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 (K020765) _Boston Scientific Corp · KTI · Apr 5, 2002 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K020765 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [KTI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI.md) - **Decision Date:** Apr 5, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4680 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Microvasive® Zero Tip™ Airway Retrieval Basket is intended to be used to endoscopically remove foreign bodies from the airway. ## Device Story The Microvasive® Zero Tip™ Airway Retrieval Basket is a manual surgical instrument used to retrieve foreign objects from the airway. The device consists of a sheath, a 4-wire rectangular basket, and an introducer. It is inserted through a bronchoscope by a physician. The operator manipulates the basket to grasp the foreign body, then retracts the basket into the sheath to secure and remove the object. The device features a 'Zero Tip' design to facilitate access. It is a mechanical tool; it does not involve electronic processing, software, or automated analysis. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical retrieval basket. Components: sheath, 4-wire rectangular basket, introducer. Working length: 120 cm. Sheath OD: 2.4 & 3.0 Fr. Features: Luer lock connector, detachable handle, Zero Tip 'X' design. Manual operation via bronchoscope. ## Regulatory Identification A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier. ## Predicate Devices - Microvasive® Zero Tip Stone Retrieval Basket (Exempt) - Olympus® Basket Grasping Forceps ([K962367](/device/K962367.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K020765 # APR = 5 2002 SECTION 14 . 510(K) SUMMARY ## FOI RELEASABLE Pursuant to §513(I)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. | Date: | March 1, 2002 | | | |-------------------------------------------------|------------------------------------------------|--------|------------| | Common/Usual Names: | Basket Graspers | | | | Trade/Proprietary Names: | Microvasive® Zero Tip™ Airway Retrieval Basket | | | | Classification Name &
Device Classification: | Class II | | | | | Name | Number | 21CFR Ref. | | | Bronchoscope & Acc. | 77 KTI | 874.4680 | | Device Panel/Branch: | Ear, Nose and Throat (ENT) | | | | Owner/Operator: | Boston Scientific Corporation | | | | | One Boston Scientific Place | | | | | Natick, MA 01760 | | | | Contact Person: | Paige Sweeney | | | | | Regulatory Affairs Specialist | | | Proprietary and Confidential Information of Boston Scientific Corporation {1}------------------------------------------------ ### Description of Devices The Microvasive® Zero Tip™ Airway Retrieval Basket is used to access the airway tree via a bronchoscope for the purpose of removing foreign objects. #### Indications for Use The Microvasive® Zero Tip™ Airway Retrieval Basket is intended to be used to endoscopically remove foreign from the airway. ## Descriptive and Technological Characteristics of Proposed and Predicate Devices Boston Scientific Corporation believes that the Microvasive® Zero Tip™ Airway Retrieval Basket is substantially equivalent to the currently marketed Microvasive® Zero Tip Stone Retrieval Basket, and the Olympus® Basket Grasping Forceps. The major components of this device are the sheath, basket, and introducer. A thorough comparison of the descriptive characteristics between the proposed device and the predicate devices show equivalence. #### Conclusion Boston Scientific Corporation has demonstrated that the Microvasive® Zero Tip™ Airway Retrieval Basket is substantially equivalent to the currently marketed Microvasive® Zero Tip Stone Retrieval Basket, and the Olympus® Basket Grasping Forceps. {2}------------------------------------------------ Substantial Equivalence for the Microvasive® Zero Tip™ Airway Retricval Basket ﻣ : | | Proposed Microvasive® Zero
Tip™ Airway Retrieval
Basket
(This 510(k)) | Microvasive® Zero Tip
Stone Retrieval Basket
(Exempt) | Olympus® Basket
Grasping Forceps
(K962367) | |--------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | USE | | | | | Indication | Intended to be used to
endoscopically remove
foreign bodies from the
airway. | Intended to be used
during urological
procedures to
endoscopically grasp,
manipulate and
remove calculi and
other foreign objects
from the urinary tract. | Intended to retrieve
foreign bodies,
calculus or tissue
specimens from the
digestive tract,
urinary tract, female
reproductive tract,
and respiratory
organs. | | Tip Design | Zero Tip "X" | Same | Molded cannula | | Basket | | | | | Basket # of
Wires | 4 | Same | 3,4 | | Basket Style | Rectangular | Same | Rectangular | | Basket Size OD
(open) | 12, 16mm | Same | 9, 10, 11, 14mm | | Sheath | | | | | Working Length | 120 cm | Same | 90 - 115cm | | Sheath OD | 2.4 & 3.0 Fr | Same | 2.4 & 3.0 Fr | | Luer Lock
Connector | Yes | Same | No | | Handle | detachable | Same | No | | Introducer | Yes | Same | No | : 上一篇: 上一篇: : : : : {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Boston Scientific Corporation c/o Paige Sweeney Microvasive Endoscopy One Boston Scientific Place Natick, MA 01760 APR = 5 2002 Re: K020765 Trade/Device Name: Microvasive Zero Tip Airway Retrieval Basket Boston Scientific Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: March 4, 2002 Received: March 8, 2002 Dear Ms. Sweeney: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ 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 our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ K020765 ## SECTION 3 INDICATIONS FOR USE To Be Determined 510(k) Number: Microvasive® Zero Tip™ Airway Retrieval Basket Device Name: a The Microvasive® Zero Tip™ Airway Retrieval Basket is Indication for Use: indicated to be used to endoscopically remove foreign bodies from the airway. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ,Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use مل Over-The-Counter Use OR (Per 21CFR 801.1091) (Optional Format 1-2-96) healt (Division Sign-Off) Division of Ophthalmic Ear, Throat Devises 0765 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K020765](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KTI/K020765) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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