(28 days)
The Microvasive® Zero Tip™ Airway Retrieval Basket is intended to be used to endoscopically remove foreign from the airway.
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.
The provided 510(k) summary for the Microvasive® Zero Tip™ Airway Retrieval Basket does not contain information about a study with acceptance criteria and reported device performance in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.
This document pertains to a physical medical device (a basket grasper) and the regulatory submission focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than a performance study with specific metrics and ground truth as would be relevant for an AI system.
Therefore, many of the requested fields cannot be populated from the provided text. I will explain why for each point.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| Explanation: This 510(k) submission is for a physical medical device (retrieval basket) and uses the "substantial equivalence" pathway. The primary "acceptance criteria" for clearance are that the new device shares fundamental technological characteristics and similar intended use with legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. There are no performance metrics like sensitivity, specificity, or accuracy that would require a study with an independent test set as is common for AI. The comparison is based on design features, material, and intended use as shown in the provided table contrasting the proposed device with predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission does not describe a performance study with a test set. The substantial equivalence argument is based on a comparison of device characteristics and intended use to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth was established as part of this submission for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission is for a physical device, not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established for a performance study. The "ground truth" equivalent in a substantial equivalence pathway is the established safety and effectiveness record of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no training set mentioned or implied for this physical device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no training set or ground truth described in this submission.
Summary of the K020765 Submission:
This 510(k) summary for the Microvasive® Zero Tip™ Airway Retrieval Basket demonstrates substantial equivalence to two predicate devices: the Microvasive® Zero Tip Stone Retrieval Basket (exempt) and the Olympus® Basket Grasping Forceps (K962367).
The core of the submission is a detailed comparison of the proposed device's characteristics (Indication, Tip Design, Basket # of Wires, Basket Style, Basket Size OD, Working Length, Sheath OD, Luer Lock Connector, Handle, Introducer) with those of the predicate devices, as presented in the table in section {2}.
The conclusion is that the proposed device is substantially equivalent because its technological characteristics and indications for use are sufficiently similar to legally marketed predicate devices, and any differences do not raise new questions of safety or effectiveness. This is a common path to market for physical medical devices and does not typically involve the elaborate performance studies required for software or AI-driven devices.
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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® ZeroTip™ Airway RetrievalBasket(This 510(k)) | Microvasive® Zero TipStone Retrieval Basket(Exempt) | Olympus® BasketGrasping Forceps(K962367) | |
|---|---|---|---|
| USE | |||
| Indication | Intended to be used toendoscopically removeforeign bodies from theairway. | Intended to be usedduring urologicalprocedures toendoscopically grasp,manipulate andremove calculi andother foreign objectsfrom the urinary tract. | Intended to retrieveforeign bodies,calculus or tissuespecimens from thedigestive tract,urinary tract, femalereproductive tract,and respiratoryorgans. |
| Tip Design | Zero Tip "X" | Same | Molded cannula |
| Basket | |||
| Basket # ofWires | 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 LockConnector | Yes | Same | No |
| Handle | detachable | Same | No |
| Introducer | Yes | Same | No |
: 上一篇: 上一篇:
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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}------------------------------------------------
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
§ 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.