(26 days)
No
The summary describes a mechanical device (locking device and biopsy cap) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as accessories (locking device and biopsy cap) intended to facilitate the use of other Rapid Exchange™ devices during ERCP procedures, specifically to lock a guidewire or facilitate device use. It does not exert a therapeutic effect on the patient.
No
The device is described as an accessory to facilitate ERCP procedures by locking a guidewire and a biopsy cap, indicating its role in assisting a medical procedure rather than diagnosing a condition.
No
The device description explicitly states it consists of a sterile, single-patient use biopsy cap and a rigid plastic guidewire locking device, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during ERCP procedures to lock a guidewire or facilitate the use of other devices. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) diagnostic test performed on biological samples.
- Device Description: The description focuses on physical accessories used with other catheter devices, not reagents, kits, or instruments for analyzing biological samples.
- Lack of Diagnostic Purpose: The text does not mention any diagnostic purpose, such as analyzing blood, urine, tissue, or other biological specimens to detect diseases, conditions, or states of health.
The device is an accessory used in a medical procedure performed on a patient, not a diagnostic test performed on a sample from a patient.
N/A
Intended Use / Indications for Use
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices:
The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.
The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.
Product codes
ODC, OCY, KOG
Device Description
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of a sterile, single-patient use biopsy cap and a rigid plastic guidewire locking device for use with other Boston Scientific Rapid Exchange catheter devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Design Verification testing has been performed to ensure that the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System meets design specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Boston Scientific has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure.
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation
Microvasive Endoscopy .
JUL 2 7 2015
Ms. Lisa Quaglia ଓ ।
:
. .
Regulatory Affairs Manager One Boston Scientific Place Natick, MA 01760-1537
Re: K010610
Trade/Device Name: Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, OCY Dated (Date on orig SE Itr): February 28, 2001 Received (Date on orig SE ltr): March 1, 2001
Dear Ms. Quaglia,
This letter corrects our substantially equivalent letter of March 27, 2001.
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
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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); 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4010610
SECTION 1 INDICATIONS FOR USE
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Device Name:
Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System
Indications for Use:
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices:
The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.
The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.1091) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
510(k) Number
Special 510(k) for Microvasive® Rapid Exchange Locking Device and Biopsy Cap System February 28, 2001 Proprietary and Confidential Information of Boston Scientific Corporation
010610
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Pg1 of
SECTION 10 510(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 either an "... 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 chooses to submit a summary of information respecting safety and effectiveness.
| Date: | February 28, 2001 |
|---|---|
| Common/Usual Name: | Biopsy Cap; Locking Device |
| Trade/Proprietary Name: | Microvasive® Rapid Exchange™ Locking Device and Biopsy |
| Cap System | |
| Classification Name & | |
| Device Classification: | Based on the regulatory class of the predicate |
| devices and the information contained in FDA's classification | |
| database, Boston Scientific Corporation believes that the | |
| Microvasive® Rapid Exchange™ Locking Device and Biopsy | |
| Cap System is best described as a Class II device with the | |
| following classification names: | |
| Name: | Endoscope and Accessories |
| Product Code: | KOG |
| 21 CFR Ref.: | 876.1500 |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal (GRDB) |
| 510(k) Sponsor & | Boston Scientific Corp. |
Contact Person:
Owner/Operator:
One Boston Scientific Place Natick, MA 01760-1537
Lisa Quaglia, Regulatory Affairs Manager
Special 510(k) for Microvasive® Rapid Exchange Locking Device and Biopsy Cap System February 28, 2001 Proprietary and Confidential Information of Boston Scientific Corporation
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Device Description:
pg 2 of 2
"Locking Device and Biopsy Cap System consists o
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of a sterile, single-patient use biopsy cap and a rigid plastic guidewire locking device for use with other Boston Scientific Rapid Exchange catheter devices.
Indications for Use:
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices.
The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.
The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.
Descriptive and Technological Characteristics of Proposed and Predicate Devices:
Boston Scientific Corporation believes that the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System is substantially equivalent to other devices in the Microvasive® Rapid Exchange™ device family, including the following:
Microvasive® Extractor Rx (K970052) Microvasive® Ultratome Rx (K970053) Microvasive® Tandem Rx (K970054)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Boston Scientific has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Design Verification testing has been performed to ensure that the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System meets design specifications.
Conclusion:
Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System has been shown to meet the minimum requirements that are considered acceptable for its intended use.
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