(56 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and testing focus on mechanical and material properties, not data processing or algorithmic functions.
No
The device is described as an "accessory" and "tool" used in conjunction with a lead introducer system to facilitate lead implantation. It does not exert a therapeutic effect on its own but rather assists in a therapeutic procedure.
No
The device is an accessory to a lead introducer system used for the implantation of leads, which is a therapeutic rather than a diagnostic function.
No
The device description and performance studies clearly indicate that this is a hardware device (accessory kit and slitter tool) used for lead implantation, with testing focused on material properties, sterilization, and physical performance. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate lead implantation in the left side of the heart via the coronary sinus." This is a surgical/interventional procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description reinforces that it's an accessory to a lead introducer system used for placing leads in the coronary sinus. This is consistent with a medical device used in a procedure, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The testing described focuses on the physical properties, biocompatibility, sterilization, and shelf life of the device, which are standard tests for medical devices used in procedures, not for IVDs.
N/A
Intended Use / Indications for Use
The Selectra Accessory Kit/Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Product codes
DQX, DQY
Device Description
The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left side of the heart via the coronary sinus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:
- Comparison of the attributes and specifications of the subject and predicate devices -
- -Subject device risk analysis
- Subject device validation testing which includes the following testing: -
New TVI Tool: - ・ Cytotoxicity
- Sensitization Local Lymph Node Assay (LLNA) -
- Irritation or Intracutaneous Reactivity י
- Acute Systemic Toxicity in the Mouse with 4 Extracts -
- Material Mediated Pyrogenicity Rabbit Pyrogen Test -
- Hemocompatibility Evaluation -
- Compendium of Biological Evaluation -
- -Eto Residual Gas Analysis
- Environmental Preconditioning -
- Release of Particulate Matter -
- Tests After Environmental Preconditioning and Shelf Life (25 months) -
- Labeling on Sales / Sterile Package Accompanying Documentation .
Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool: - Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of -Unit
- Inspection of Seldinger Guide Wire -
- -Inspection of Syringe
- Inspection of Check Valve, Stop-Cock, and Sealing Caps -
- Inspection of TVI and slitter tool -
- Proof of Sterilization after Accelerated Aging of 25 Months -
New Sterile Packaging for the Selectra Slitter Tool: - Labelling on Sales / Sterile Package Accompanying Documentation 1
- Environmental Preconditioning -
- Determination of Shelf Life (25 months) and Integrity of Sterile Packaging -
- י EtO Sterilization Cycle Product Adoption
- . Tests after Environmental Preconditioning and Accelerated Aging (25 Months)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Selectra Accessory Kit and Selectra Slitter Tool Modifications
Special 510(k) Premarket Notification
1. 510(K) SUMMARY
| Date Prepared: | August 22, 2013 |
|---|---|
| Name and Address of Sponsor: | BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
AUG 2 3 2013
| Establishment Registration Number: | 1028232 |
|---|---|
| 510(k) Contact Person and Phone Number: | Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: (800) 913-6993 jon.brumbaugh@biotronik.com |
Device Name:
| Proprietary Name: | Selectra Accessory Kit, Selectra Slitter Tool |
|---|---|
| Common Name: | Catheter Guide wire |
| Classification: | Class II (21 CFR 870.1330) |
| Product Code: | DQX, DQY |
Predicate Devices:
- . Selectra Accessory Kit (K111839, dated September 26, 2011)
- Selectra Slitter Tool (K112482, dated September 26, 2011) .
Indications for Use:
The Selectra Accessory Kit/Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Device Modifications:
The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.
Technological Characteristics and Substantial Equivalence:
The substantial equivalence claim between the subject and the predicate device is supported by the information included in the premarket notification. This includes the following information:
- -Description of the subject and predicate devices
- Intended use of the subject and predicate devices -
- Performance of the subject and predicate devices -
- Technological characteristics of the subject and predicate devices -
- Validation Testing -
1
:
| Table 1: Substantial Equivalence of the Modified Selectra Accessory Kit and
| Selectra Slitter Tool | ||
|---|---|---|
| Technical Data | Selectra Accessory Kit | |
| (Predicate) | Selectra Accessory Kit | |
| (Proposed) | ||
| Configuration | 1 Accessory Kit Including: |
- 1 Guide Wire
- 4 Transvalvular Insertion
(TVI) Tools - 1 Selectra Slitter Tool
- 1 Torquer
- 2 Check-valves
- 2 Stop-cocks
- 2 Sealing Caps
- 1 Syringe
- Technical Manual | 1 Accessory Kit Including:
- 1 Guide Wire
- 4 Transvalvular Insertion
(TVI) Tools (subject of this
Special 510(k)) - 1 Selectra Slitter Tool
- 1 Torquer
- 2 Check-valves
- 2 Stop-cocks
- 2 Sealing Caps
- 1 Syringe
- Technical Manual |
| TVI Tool Design | Image: TVI Tool Design Predicate | Image: TVI Tool Design Proposed |
| Dimensions
Materials | Outer Diameter: 5 F
Inner Diameter: 3 F
PTFE, PP | Outer diameter: 4.8 F
Inner diameter: 1.26 F
PEBAX 7233 |
| Manufacturer | Galt Medical Corp. | BIOTRONIK SE & Co. KG |
| Product Packaging | The products are packaged in a sterile blister within a sterile
pouch. The blister and pouch are placed in an outer
cardboard box with label and a quality seal. | |
| EtO Sterilization | EtO sterilization for single use only. The sterilization process
is validated at least bi-annually. | |
| Shelf Life | 6 months | 2 years |
| Technical Data | Selectra Slitter Tool
(Predicate) | Selectra Slitter Tool
(Proposed) |
| Selectra Slitter Tool
Design | Image: Selectra Slitter Tool Predicate | Image: Selectra Slitter Tool Proposed |
| Compatibility | Can be used with all coronary sinus leads with a diameter of
4.6F to 5.8 F. | |
| Materials | Body Material - Acrylonitrile Butadiene
Blade Material - Stainless Steel | |
| Manufacturer | Creganna | |
| Product Packaging | The products are packaged
in a sterile blister within a
sterile pouch. The blister and
pouch are placed in an outer
cardboard box with label and
a quality seal. | The products are packaged
in two sterile pouches. Both
pouches are placed in an
outer cardboard box with
label and a quality seal. |
| EtO Sterilization | EtO sterilization for single use only. Sterilization process is
validated at least bi-annually. | |
| Shelf Life | 6 months | 2 years |
.
:
.
ﺳ
. .'
2
Page 3 of 3
Summary of Non-Clinical Testing:
The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:
- Comparison of the attributes and specifications of the subject and predicate devices -
- -Subject device risk analysis
- Subject device validation testing which includes the following testing: -
New TVI Tool:
- ・ Cytotoxicity
- Sensitization Local Lymph Node Assay (LLNA) -
- Irritation or Intracutaneous Reactivity י
- Acute Systemic Toxicity in the Mouse with 4 Extracts -
- Material Mediated Pyrogenicity Rabbit Pyrogen Test -
- Hemocompatibility Evaluation -
- Compendium of Biological Evaluation -
- -Eto Residual Gas Analysis
- Environmental Preconditioning -
- Release of Particulate Matter -
- Tests After Environmental Preconditioning and Shelf Life (25 months) -
- Labeling on Sales / Sterile Package Accompanying Documentation .
Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:
- Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of -Unit
- Inspection of Seldinger Guide Wire -
- -Inspection of Syringe
- Inspection of Check Valve, Stop-Cock, and Sealing Caps -
- Inspection of TVI and slitter tool -
- Proof of Sterilization after Accelerated Aging of 25 Months -
New Sterile Packaging for the Selectra Slitter Tool:
- Labelling on Sales / Sterile Package Accompanying Documentation 1
- Environmental Preconditioning -
- Determination of Shelf Life (25 months) and Integrity of Sterile Packaging -
- י EtO Sterilization Cycle Product Adoption
- . Tests after Environmental Preconditioning and Accelerated Aging (25 Months)
Conclusion:
BIOTRONIK considers the modifications to the Selectra Accessory Kit and Selectra Slitter Tool to be substantially equivalent to the legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem consisting of three curved shapes, which are meant to represent the department's mission of promoting health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
Biotronik, Inc. Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035 US
Re: K131978
Trade/Device Name: Selectra Accessory Kit, Selectra Slitter Tool Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DQY Dated: July 24, 2013 Received: July 25, 2013
Dear Mr. Brumbaugh:
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 vour 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. 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
4
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.
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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M.A. Gilliland
_
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131978
Device Name: Selectra Accessory Kit and Selectra Slitter Tool Indications for Use:
The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
MA Hillman