(121 days)
Not Found
No
The device description and performance studies focus on mechanical properties and function, with no mention of AI/ML terms or capabilities.
Yes
The device is intended to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects by dilating tissue, which is a therapeutic intervention.
No
The device is described as a dilator sheath set intended for the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, catheters, and foreign objects. Its function is to physically dilate tissue, not to diagnose conditions or diseases.
No
The device description clearly describes physical components (inner and outer polymer sheaths) and performance studies related to physical properties (dimensional verification, tensile, bend, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, catheters, and foreign objects. This is a surgical or interventional procedure performed on the patient's body.
- Device Description: The description details a physical device (sheaths) used to mechanically dilate tissue. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The LexiPliant™ Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Design Verification and Validation Testing
- Dimensional Verification
- Tensile
- Cantilever Bend
- Dilatation
- Tip Compression
- Torque Tip
- Sheath Cycle
- Kink Fatigue
- Radiopacity
Sterilization
- Product adoption equivalency per AAMI TIR:28-2009
Biocompatibility
- Physiochemical
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Reactivity
- Acute Systemic Toxicity
- C3a and SC5b-9 Complement Activation
- Indirect and direct Hemolysis
- In Vivo Thromobogenicity-Dog Model
- Material Mediated Pyrogenicity
- Genotoxicity – Ames Test
Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification test results demonstrated that the subject device is as safe and clinically effective as the predicate device.
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.
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
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
MAR 2 7 2
510(k) Summary, K133631, page
Spectranetics
Always Reaching Farther
510(k) Summary
This 510(k) summary was prepared in accordance with 21 CFR 807.92(c)
Prepared on March 11. 2014
| 510(k) Submitter / Holder: | Spectranetics
9965 Federal Drive
Colorado Springs, CO 80921.3617
Establishment Registration No: 3007284006 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Pharoah Garma
Regulatory Affairs Manager
Office: 719.447.2385
Fax: 719.447.2040
Email: Pharoah.Garma@SPNC.com |
Subject Device
| Device Trade Name: | |
|---|---|
| Device Common Name: | |
| Device Class: | |
| Classification Regulation: | |
| Regulation Description: | |
| Product Code: | |
| 510(k) Type: | |
| Model Numbers: |
LexiPliant™ Dilator Sheath Set Dilator Sheath 21 CFR 870 1310 Vessel dilator for percutaneous catheterization DRE Traditional Standard: 550-008, 550-010, 550-011, 550-013 Long: 555-508, 555-510, 555-511, 555-513
Predicate Device
The LEXiPliant Dilator Sheath Sets were compared to the following legally marketed predicate device:
| 510(k) Number: | K0923 |
|---|---|
| Manufacturer: | Spectra |
| Trade Name: | VisiShe |
| Device Common Name: | Dilator |
78 (cleared on November 02, 2009) anetics Corp. eath™ Dilator Sheath Sheath
Device Description
The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.
Intended and Indications for Use
The LexiPliant Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.
1
Technological Characteristics
The LexiPliant Dilator Sheath Set features similar design and functional characteristics as the predicate device (K092378 - VisiSheath Dilator Sheath Set). The results of design verification and validation testing demonstrate that the subject device is as safe and clinically effective as the predicate device.
Performance Data
The following testing was conducted to validate and verify that the subject device met was substantially equivalent to the predicate device:
Design Verification and Validation Testing
- . Dimensional Verification
- Tensile .
- Cantilever Bend .
- . Dilatation
- Tip Compression .
- Torque Tip �
- Sheath Cycle .
- Kink Fatigue .
- Radiopacity ●
Sterilization
- . Product adoption equivalency per AAMI TIR:28-2009
Biocompatibility
- Physiochemical .
- Cytotoxicity ●
- Sensitization .
- Irritation/Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- C3a and SC5b-9 Complement Activation .
- Indirect and direct Hemolysis .
- In Vivo Thromobogenicity-Dog Model .
- Material Mediated Pyrogenicity .
- . Genotoxicity – Ames Test
Preclinical and Clinical Data:
Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification test results demonstrated that the subject device is as safe and clinically effective as the predicate device.
Substantial Equivalence
Based on the similarities in design between the subject and predicate device, and the performance data, the LexiPliant Dilator Sheath Set is substantially equivalent to the VisiSheath Dilator Sheath Set (K092378).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2014
Specranetics Corporation % Pharoah Garma Regulatory Affairs Manager 9965 Federal Drive Colorado Springs, CO 80921-3617
Re: K133631
Trade/Device Name: LexiPliant™ Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: February 25, 2014 Received: February 26, 2014
Dear Ms. Garma,
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.
3
Page 2 - Pharoah Garma
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 devicerelated 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 tollfree 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" (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.
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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133617
Device Name LexiPliant™ Dilator Sheath Set
Indications for Use (Describe)
The LexiPlianTM Dilator Sheath Set is intended for use in patients requiring the perculaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.
Bram D. Zuckerman -S 2014.03.27 16:38:50 -04'00'
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)