(107 days)
No
The device description and performance testing focus on the physical characteristics and material properties of a renal sheath, with no mention of AI or ML capabilities.
No.
The device is used to establish percutaneous access for instrumentation, not to treat a disease or medical condition.
No
Explanation: The device is described as a "Renal Sheath" and its intended use is for "establishment of percutaneous access" for instrumentation. This indicates it is an access device for therapeutic or interventional procedures, not a diagnostic device that performs analysis or identifies conditions.
No
The device description explicitly details physical components made of PTFE material, including tubing, tips, and radiopaque markers. The performance testing also focuses on physical characteristics and material properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the establishment of percutaneous access." This describes a surgical or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details physical characteristics of a sheath used for access during a procedure. It doesn't mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties and biocompatibility of the device for its intended use in a procedure. They do not involve evaluating the device's ability to diagnose a condition based on sample analysis.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device is used in the body to facilitate access, not to perform a diagnostic test on a sample from the body.
Therefore, the Amplatz Type Renal Sheath, Amplatz Type Renal Sheath Set, and Clear Renal Sheath are medical devices used for interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.
The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access.
The Clear Renal Sheath is recommended for the establishment of percutaneous access.
Product codes
LJE
Device Description
Amplatz Type Renal Sheaths
The Amplatz Type Renal Sheaths are manufactured from extruded tubing and are available in 17cm lengths with the following interior diameters in French units (F): 14F, 16F, 18F, 20F, 22F, 24F, 26F, 28F and 30F. A 20cm length renal sheath with a 30F interior diameter is also available. The Amplatz Type Renal Sheaths are constructed of blue PTFE (polytetrafluoroethylene) material, which is bismuth loaded for fluoroscopy. The tip is designed for atraumatic placement and ease of advancement over dilators or balloons.
Amplatz Type Renal Sheath Set
The Amplatz Type Renal Sheath Set includes four 17cm length (single) Amplatz Type Renal Sheaths (offered in sizes: 24F, 26F, 28F and 30 F). There are no differences between the renal sheaths offered in the Amplatz Type Renal Sheath Set and the abovementioned Amplatz Type Renal Sheaths. Aside from the renal sheaths, the Amplatz Type Renal Sheath Set contains no additional components.
Clear Renal Sheath
The Clear Renal Sheath is a 30F, 17 cm length sheath with a guidewire notch at the proximal end and a radiopaque marker at the distal tip. Renal sheaths are used to establish percutaneous access for instrumentation.
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
Boston Scientific has conducted performance testing with representative samples of the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath.
The performance testing included:
- Sheath Length
- Sheath Outer Diameter
- Sheath Distal Tip Shape
- Sheath Distal Tip Inner Diameter
- Sheath Inner Diameter
- Sheath Proximal End OD Edge
- Guidewire Compatibility (Clear Renal Sheath only)
- Radiopaque Marker Location (Clear Renal Sheath only)
- Compression Strength (Clear Renal Sheath only)
The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath were evaluated in accordance with EN ISO 10993-1: 2009. The following tests were performed on the devices: MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity and Acute Systemic Injection.
All testing performed met requirements. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are considered safe and effective for their intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
January 10, 2018
Boston Scientific Corporation Daniel FitzDaniel Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K172929
Trade/Device Name: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: December 8, 2017 Received: December 11, 2017
Dear Daniel FitzDaniel:
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 or any Federal statutes and regulations administered by other Federal agencies.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) To be determined. K 172929
Device Name
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath
Indications for Use (Describe)
The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.
The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access.
The Clear Renal Sheath is recommended for the establishment of percutaneous access.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5
510(k) SUMMARY
510(k) Summary for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath
A. Sponsor
Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Daniel FitzDaniel Specialist, Regulatory Affairs 508-683-4156 Dan.FitzDaniel@bsci.com or
Virginia Garcia Manager, Regulatory Affairs 508-683-4430 Virginia.Garcia@bsci.com
Date Prepared: 8 December 2017
C. Device Name
| Trade name: | Amplatz Type Renal Sheaths, Amplatz Type Rena
Sheath Set, Clear Renal Sheath |
|----------------------|---------------------------------------------------------------------------------|
| Common/usual name: | Catheter, Nephrostomy |
| Classification Name: | None |
| Regulation Name: | Unclassified |
| Regulation Class: | II |
| Product Code: | LJE |
| Panel: | Gastroenterology/Urology |
D. Predicate Device
| Trade name: | Ultraxx™ Nephrostomy Balloon Set |
|---|---|
| Common/usual name: | Catheter, Nephrostomy |
| Classification Name: | LJE – Catheter, Nephrostomy |
Premarket Notification: K024050, February 27, 2003 Ultraxx TM Nephrostomy Balloon Set (formerly Cook Nephrostomy Balloon Dilation Catheter Set, Cook Urological, Inc., Spencer, IN)
E. Device Description
Amplatz Type Renal Sheaths
Proprietary and Confidential Information of Boston Scientific Corporation
4
SECTION 5
510(k) SUMMARY
The Amplatz Type Renal Sheaths are manufactured from extruded tubing and are available in 17cm lengths with the following interior diameters in French units (F): 14F, 16F, 18F, 20F, 22F, 24F, 26F, 28F and 30F. A 20cm length renal sheath with a 30F interior diameter is also available. The Amplatz Type Renal Sheaths are constructed of blue PTFE (polytetrafluoroethylene) material, which is bismuth loaded for fluoroscopy. The tip is designed for atraumatic placement and ease of advancement over dilators or balloons.
Amplatz Type Renal Sheath Set
The Amplatz Type Renal Sheath Set includes four 17cm length (single) Amplatz Type Renal Sheaths (offered in sizes: 24F, 26F, 28F and 30 F). There are no differences between the renal sheaths offered in the Amplatz Type Renal Sheath Set and the abovementioned Amplatz Type Renal Sheaths. Aside from the renal sheaths, the Amplatz Type Renal Sheath Set contains no additional components.
Clear Renal Sheath
The Clear Renal Sheath is a 30F, 17 cm length sheath with a guidewire notch at the proximal end and a radiopaque marker at the distal tip. Renal sheaths are used to establish percutaneous access for instrumentation.
F. Intended Use
Amplatz Type Renal Sheath and Amplatz Type Renal Sheath Set The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.
Clear Renal Sheath
The Clear Renal Sheath is recommended for the establishment of percutaneous access.
G. Indications for Use
Same as Intended Use.
H. Technological Characteristics
The Amplatz Type Renal Sheaths and Amplatz Type Renal Sheath Set consist of an extruded tube (made of radiopaque PTFE) that has a tapered tip designed for atraumatic placement and ease of advancement over dilators or balloons.
The Clear Renal Sheath consists of an extruded tube made of clear polyvinyl chloride with a guide-wire notch at the proximal end and a radiopaque marker at the distal tip. The Clear Renal Sheath has a tapered tip designed for atraumatic placement and ease of advancement over dilators or balloons.
I. Substantial Equivalence
A direct comparison of key characteristics has been performed and demonstrates that the proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are substantially equivalent to the predicate device in terms of intended use,
Proprietary and Confidential Information of Boston Scientific Corporation
5
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set & Clear Renal Sheath Boston Scientific Traditional 510(k)
SECTION 5
510(k) SUMMARY
technological characteristics, method of sterilization and performance characteristics. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are as safe and effective as the predicate device.
J. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with representative samples of the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath.
The performance testing included:
- Sheath Length
- Sheath Outer Diameter
- Sheath Distal Tip Shape
- Sheath Distal Tip Inner Diameter
- Sheath Inner Diameter
- Sheath Proximal End OD Edge
- Guidewire Compatibility (Clear Renal Sheath only)
- Radiopaque Marker Location (Clear Renal Sheath only) ●
- Compression Strength (Clear Renal Sheath only)
The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath were evaluated in accordance with EN ISO 10993-1: 2009. The following tests were performed on the devices: MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity and Acute Systemic Injection.
All testing performed met requirements. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are considered safe and effective for their intended use.
Conclusion
The information provided in this submission demonstrate that the proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are substantially equivalent to the renal sheath which is a kit component in the Ultraxx™ Nephrostomy Balloon Set cleared in K024050.