(31 days)
Not Found
No
The description focuses on the mechanical function and physical characteristics of a catheter delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an introducer system for pacemaker leads, facilitating their placement but not providing direct therapeutic action itself.
No
Explanation: The device is described as an introducer system for pacemaker leads, facilitating their implantation by providing access to the coronary venous system. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition. Its purpose is purely interventional/therapeutic.
No
The device description clearly details a physical delivery system including catheters, dilators, hemostatic valves, and a slitter tool, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for introducing leads into the vessels of the left heart via the coronary sinus. This is a procedure performed in vivo (within the living body) for therapeutic purposes (implanting pacemaker leads).
- Device Description: The description details a delivery system for implanting leads, involving catheters, dilators, and a hemostatic valve. These are all tools used for surgical or interventional procedures on a patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ScoutPro 7F does not perform any such analysis of bodily specimens.
The ScoutPro 7F is a medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DRE, DQX
Device Description
ScoutPro 7F is a special delivery system for coronary sinus leads. It is clesigned to assist with introducing leads into the vessels of the left side of the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's current legally marketed predicate device ScoutPro (K033320, 11-19-2003).
The basic set ScoutPro 7F contains the following components:
- 1 hemostatic valve
- 2 guiding catheters MPEP and BIO 2
- 1 dilator for the guiding catheter
- 1 peel-away sheath 10F with dilator
- 1 guide wire
- 1 needle
- 1 syringe
- 2 slitter tools 4.9 F and 6.3 F for different lead sizes
ScoutPro 7F Sheath "Hook" contains the following components:
- 1 guiding catheter "Hook"
- 1 dilator for the guiding catheter
ScoutPro 7F Sheath "Multi-Purpose Hook" contains the following components:
- 1 guiding catheter "Multi-Purpose Hook"
- 1 dilator for the guiding catheter
ScoutPro 7F 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.
The main difference between the predicate device ScoutPro and the ScoutPro 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Some other modifications include changes to the accessories like the markings on the hemostatic valve, a larger scaled syringe and a different plastic material for slitter tools.
The ScoutPro 7F functions similarly to that of a standard introducer for pacemaker leads. It contains catheters with various distal arcs to facilitate and support the implantation of left-ventricular polyurethane leads up to 6.6 F in the coronary venous system. For implantation of left ventricular pacing leads, the subclavian or the cephalic vein is used as a point of entry into the venous system. After gaining access to the vein, one of the braided, peel-away guiding catheters (long sheaths) used in combination with the dilator and hemostatic valve is introduced into the vein using a guide wire initially positioned in the atrium. Selection of a guiding catheter with a suitable curve (arc) allows the distal tip of the catheter to probe the coronary sinus and facilitates implantation of the lead into the coronary veins. A side access in the hemostatic valve enables the injection of irrigation solutions and contrast dyes to facilitate gaining access to the coronary sinus. After successful placement of the hemostatic valve and the guiding catheter are removed over the lead. In this process, the pre-slitted peel-away grip, which is glued to the proximal end of the guiding catheter, is broken off. The catheter is opened along the pre-slit portion (2 cm). Then, using the slitter tool, the guiding catheter is slit from proximal to distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left heart, coronary sinus, subclavian or the cephalic vein
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): 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
§ 870.1250 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
K060807 page 1
March 23, 2006
ScoutPro 7F Special 510(k) Premarket Notification
APR 24 4000
1. 510(k) SUMMARY
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
Device Name:
Proprietary Name: ScoutPro 7F Classification: Class II (21 CFR 870.1250; 870.1310; 870.1330) Classification Name: Wire, Guide, Catheters, Percutaneous Product Code: DQY, DRE, DQX
General Description:
ScoutPro 7F is a special delivery system for coronary sinus leads. It is clesigned to assist with introducing leads into the vessels of the left side of the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. It is a modified version of BIOTRONIK's current legally marketed predicate device ScoutPro (K033320, 11-19-2003). The following ScoutPro 7F accessories are subject to this Special 510 (k)
1028232
The basic set ScoutPro 7F contains the following components:
- 1 hemostatic valve
- · 2 guiding catheters MPEP and BIO 2
- · 1 dilator for the guiding catheter
- 1 peel-away sheath 10F with dilator
- · 1 guide wire
- 1 needle
- · 1 syringe
- · 2 slitter tools 4.9 F and 6.3 F for different lead sizes
ScoutPro 7F Sheath "Hook" contains the following components:
- · 1 guiding catheter "Hook"
- · 1 dilator for the guiding catheter
ScoutPro 7F Sheath "Multi-Purpose Hook" contains the following components:
- · 1 guiding catheter "Multi-Purpose Hook"
- · 1 dilator for the guiding catheter
ScoutPro 7F Sheath "Amplatz 6.0" contains the following components:
- · 1 guiding catheter "Amplatz 6.0"
- · 1 dilator for the guiding catheter
1
BIOTRONIK, ScoutPro 7F, Special 510(k)
... March 23, 2006
Additionally, the hemostatic valve and the slitter tools are available separately. The hemostatic valve and slitter tool 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 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Some other modifications include changes to the accessories like the markings on the hemostatic valve, a larger scaled syringe and a different plastic material for slitter tools.
Predicate Device:
BIOTRONIK proposes the following delivery system cleared through 510(k) notification as a predicate device for the ScoutPro 7F:
BIOTRONK's ScoutPro (#K033320, 11-19-2003) .
Indication for Use:
The intended use of the ScoutPro 7F 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 |
2
K060807 Page 3
March 23, 2006
2. INDICATIONS FOR USE
The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.
See Appendix 1 for the 510(k) Indications for Use Form.
3. CONTRAINDICATIONS
The ScoutPro 7F is contraindicated for:
- · Patients with known or possible obstructed coronary sinus vasculature or inadequate coronary sinus anatomy.
- · Patients with active systemic infection.
4. DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE PRODUCTS
4.1 DEVICE DESCRIPTION
The ScoutPro 7F delivery system is a modified version of the BIOTRONIK's current legally marketed ScoutPro delivery system (K03320, dated 11-19-2003). The ScoutPro 7F functions similarly to that of a standard introducer for pacemaker leads. It contains catheters with various distal arcs to facilitate and support the implantation of left-ventricular polyurethane leads up to 6.6 F in the coronary venous system.
For implantation of left ventricular pacing leads, the subclavian or the cephalic vein is used as a point of entry into the venous system. After gaining access to the vein, one of the braided, peel-away guiding catheters (long sheaths) used in combination with the dilator and hemostatic valve is introduced into the vein using a guide wire initially positioned in the atrium. Selection of a guiding catheter with a suitable curve (arc) allows the distal tip of the catheter to probe the coronary sinus and facilitates implantation of the lead into the coronary veins. A side access in the hemostatic valve enables the injection of irrigation solutions and contrast dyes to facilitate gaining access to the coronary sinus.
After successful placement of the hemostatic valve and the guiding catheter are removed over the lead. In this process, the pre-slitted peel-away grip, which is glued to the proximal end of the guiding catheter, is broken off. The catheter is opened along the pre-slit portion (2 cm). Then, using the slitter tool, the guiding catheter is slit from proximal to distal end.
The main difference between the predicate device ScoutPro and the ScoutPro 7F described in this documentation is the inner diameter of the guiding catheters included in the system. Most coronary sinus leads to be implanted have a smaller diameter, for which a 7F introducer system is sufficient. A comparison table with the predicate device ScoutPro is provided in Section 4.2.
The basic set ScoutPro 7F (Figure 1) contains the following components with changes (if any) listed in Table 1.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2006
Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K060807
Trade/Device Name: ScoutPro 7F Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 23, 2006 Received: March 24, 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.
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
4
Page 2 - Mr. Jon Brumbaugh
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,
B.Bimmerman for
Bram D. Zuckerman, MD 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):
Device Name: ScoutPro 7F
Indications for Use:
The intended use of the ScoutPro 7F is for introducing leads into the vessels of the left heart via the coronary sinus.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
P
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Blummo
issen Slon-Off Division of Cardlov scular De 510/2) Number
2