Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

K172929 · Boston Scientific Corporation · LJE · Jan 10, 2018 · GU

Device Facts

• Record ID: K172929
• Device Name: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
• Applicant: Boston Scientific Corporation
• Product Code: LJE · GU
• Decision Date: Jan 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended 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.

Device Story

Amplatz Type Renal Sheaths and Clear Renal Sheath are tubular devices used to establish percutaneous access during urological procedures. Amplatz Type sheaths are extruded PTFE (bismuth-loaded for fluoroscopy) available in 14F-30F sizes; Clear Renal Sheath is extruded PVC with a proximal guidewire notch and distal radiopaque marker. Devices feature tapered tips for atraumatic advancement over dilators or balloons. Used by urologists in clinical settings to maintain access tracts for instrumentation. Output is a physical conduit for surgical tools. Benefits include facilitated access to the renal system for minimally invasive procedures.

Clinical Evidence

Bench testing only. Evaluations included sheath dimensions (length, diameter), tip shape, guidewire compatibility, radiopaque marker location, and compression strength. Biocompatibility testing performed per EN ISO 10993-1:2009, including MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity, and Acute Systemic Injection. All tests met requirements.

Technological Characteristics

Amplatz Type: Extruded PTFE, bismuth-loaded, 14F-30F diameters, 17cm-20cm lengths. Clear Renal Sheath: Extruded PVC, 30F, 17cm length, proximal guidewire notch, distal radiopaque marker. Both feature tapered tips for atraumatic placement. Sterilization method not specified.

Indications for Use

Indicated for patients requiring percutaneous access to the renal system for instrumentation.

Predicate Devices

• Ultraxx™ Nephrostomy Balloon Set (K024050)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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 [e-mail] or

Virginia Garcia Manager, Regulatory Affairs 508-683-4430 [e-mail]

Date Prepared: 8 December 2017

### C. Device Name

| Trade name: | Amplatz Type Renal Sheaths, Amplatz Type Rena<br>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

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# 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

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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.