Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical retrieval basket and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is used for the removal of foreign objects, which is an interventional procedure, not a therapeutic one in the sense of treating a disease or condition.

Diagnostic

No
Explanation: The device is intended for the removal of foreign objects from the airway, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly lists physical components (sheath, basket, introducer) and describes a physical action (endoscopically remove foreign objects), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "endoscopically remove foreign from the airway." This is a therapeutic or interventional procedure performed directly on the patient's body.
Device Description: The description details a physical device used for retrieval within the airway, not for analyzing samples of human origin outside the body.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease
- Using reagents or assays

IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for physical removal of foreign objects, which falls outside the scope of IVD regulation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Microvasive® Zero Tip™ Airway Retrieval Basket is intended to be used to endoscopically remove foreign from the airway.

Product codes (comma separated list FDA assigned to the subject device)

KTI

Device Description

The Microvasive® Zero Tip™ Airway Retrieval Basket is used to access the airway tree via a bronchoscope for the purpose of removing foreign objects. The major components of this device are the sheath, basket, and introducer.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K962367

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.

Summary

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 |

:

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