(22 days)
No
The device description focuses on mechanical components and accessories for lead delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a delivery system designed to assist with introducing leads into the coronary sinus, not to treat a condition itself.
No
The device description clearly states its purpose is for introducing leads into the heart, facilitating access, and probing the coronary sinus. None of these functions are diagnostic, but rather procedural.
No
The device description explicitly lists multiple hardware components, including catheters, sheaths, dilators, guide wires, needles, syringes, and slitter tools. This indicates it is a physical medical device, not software-only.
Based on the provided information, the ScoutPro 8F is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "introducing leads into the vessels of the left heart via the coronary sinus." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device components (guiding catheters, dilators, sheaths, guide wire, needle, syringe, slitter tools, hemostatic valve) are all instruments used in a surgical or interventional procedure. They are not reagents, kits, or instruments designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor is there any indication of providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The ScoutPro 8F's function is to facilitate a medical procedure, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.
Product codes
DQY, DRE, DQX
Device Description
ScoutPro 8F is a special delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left heart via the coronary sinus. It facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's currently legally marketed predicate device, ScoutPro (K033320, 11-19-2003). The following ScoutPro 8F accessories are subject to this 510(k)
The basic set ScoutPro 8F contains the following components:
- 1 hemostatic valve
- 2 guiding catheters Blo I and Blo 2
- 1 dilator for the guiding catheter
- 1 peel-away sheath 11F with dilator
- 1 guide wire
- 1 needle
- 1 syringe
- 2 slitter tools 4.9 F and 6.3 F for different lead sizes
ScoutPro 8F Sheath "Hook" contains the following components:
- 1 quiding catheter "Hook"
- 1 dilator for the guiding catheter
ScoutPro 8F Sheath "Multi-Purpose Hook" contains the following components:
- 1 guiding catheter "Multi-Purpose Hook"
- 1 dilator for the guiding catheter
ScoutPro 8F Sheath "Amplatz 6.0" contains the following components:
- 1 guiding catheter "Amplatz 6.0"
- 1 dilator for the guiding catheter
Additionally, the hemostatic valve and the slitter tools are available separately. These accessories have been cleared with the legally marketed predicate device ScoutPro (K033320, 11-19-2003).
Device Modification:
The main difference between the predicate device ScoutPro and the ScoutPro 8F described in this documentation are some modifications with the accessories included in the system. The changes to the accessories include the markings on the hemostatic valve, a bigger scaled syringe and a different plastic material and a different steel blade for slitter tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left 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)
Not Found
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
K 060655
March 10, 2006
ScoutPro 8F Special 510(k) Premarket Notification
APR
1. 510(k) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
4 2006
Establishment Registration Number:
1028232
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
ScoutPro 8F Class II (21 CFR 870.1250; 870.1310; 870.1330) Catheters, Percutaneous DQY, DRE, DQX
General Description:
ScoutPro 8F is a special delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left heart via the coronary sinus. It facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's currently legally marketed predicate device, ScoutPro (K033320, 11-19-2003). The following ScoutPro 8F accessories are subject to this 510(k)
The basic set ScoutPro 8F contains the following components:
1 hemostatic valve
- 2 guiding catheters Blo I and Blo 2
- 1 dilator for the guiding catheter
- 1 peel-away sheath 11F with dilator
- 1 guide wire
- 1 needle
- 1 syringe
2 slitter tools 4.9 F and 6.3 F for different lead sizes
ScoutPro 8F Sheath "Hook" contains the following components:
1 quiding catheter "Hook"
1 dilator for the guiding catheter
ScoutPro 8F Sheath "Multi-Purpose Hook" contains the following components:
1 guiding catheter "Multi-Purpose Hook"
1 dilator for the guiding catheter
ScoutPro 8F Sheath "Amplatz 6.0" contains the following components:
1 guiding catheter "Amplatz 6.0"
1 dilator for the guiding catheter
Additionally, the hemostatic valve and the slitter tools are available separately. These accessories have been cleared with the legally marketed predicate device ScoutPro (K033320, 11-19-2003).
Device Modification:
The main difference between the predicate device ScoutPro and the ScoutPro 8F described in this documentation are some modifications with the accessories included in the system. The changes to the accessories include the markings on the hemostatic valve, a bigger scaled syringe and a different plastic material and a different steel blade for slitter tools.
1
Predicate Device:
BIOTRONIK proposes the following delivery system cleared through 510(k) notification as a predicate device for the ScoutPro 8F:
- BIOTRONIK's ScoutPro (#K033320, 11-19-2003) .
Indication for Use:
The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.
| Name and Address of Manufacturer: | BIOTRONIK GmbH & Co. KG (reg. no. 9610139)
Woermannkehre 1,
12359 Berlin, Germany |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | 011-49-30-689-05-1210 |
| Name and Address of Contract Manufacturer: | BIOTRONIK AG (reg. no. 8043892)
Ackerstrasse 6
8180 Bülach,
Switzerland 011-41-44-864-5169 |
| Contact Person(s) and Phone Number: | Jon Brumbaugh
Director, Regulatory Affairs and Compliance
Phone (888) 345-0374
Fax (503) 635-9936
jon.brumbaugh@BIOTRONIK.com |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four human figures. The logo is encircled by the words "U.S. Department of Health and Human Services".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006 APR
Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K060655
Trade Name: ScoutPro 8F Coronary Sinus Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 10, 2006 Received: March 13, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Jon Brumbaugh
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmon for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ScoutPro 8F
Indications for Use:
The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.
V 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)
Slan-Off
Division of Cardlovascular Devices 5100
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