(35 days)
No
The device description focuses on mechanical components and accessories for lead introduction, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The document states that the intended use of the device is for 'introducing leads into the vessels of the left heart via the coronary sinus' and 'facilitates access to the coronary sinus venous system as well as probing of the coronary sinus', indicating an assistive or access-providing function rather than a direct therapeutic effect.
No
The device is described as assisting in introducing leads into vessels and facilitating access to the coronary sinus venous system, which points to a therapeutic or interventional function, not diagnostic.
No
The device description explicitly lists multiple physical components such as catheters, dilators, sheaths, guide wires, needles, syringes, and slitter tools, indicating it is a hardware-based medical device.
Based on the provided information, the ScoutPro 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 describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The components listed (catheters, sheaths, guide wires, needles, etc.) are all instruments used for accessing and navigating within the vascular system during a medical procedure. They are not reagents, analyzers, or other components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory tests.
Therefore, the ScoutPro is a medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the ScoutPro 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
Device Description
The ScoutPro 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 of the coronary sinus. The ScoutPro has been expanded and modified from BIOTRONIK's currently legally marketed SCOUT (K020821, 06-03-02). The following ScoutPro accessories are the subjects of this 510(K);
ScoutPro 8F that contains the following components:
- . 1 hemostatic valve
- . 2 guiding catheters BIO 1 and BIO 2
- 1 dilator for the quiding catheter .
- 1 peel-away sheath 11F
- 1 guide wire ●
- 1 needle .
- 1 svringe
- 2 slitter tools 4.9 F and 6.3 F for different lead sizes ●
ScoutPro Sheath "Hook" that contains the following components:
- . 1 quiding catheter "Hook"
- 1 dilator for the guiding catheter .
ScoutPro Sheath "Multi-Purpose Hook" that contains the following components:
- 1 guiding catheter "Multi-Purpose Hook" .
- 1 dilator for the guiding catheter .
ScoutPro Sheath "Amplatz 6.0" contains the following components:
- . 1 quiding catheter "Amplatz 6.0"
- . 1 dilator for the guiding catheter
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): 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
Image /page/0/Picture/1 description: The image shows the text "KO33320" in a bold, handwritten-like font. Below this, the date "October 13, 2003" is printed in a clear, sans-serif font. The text and date are aligned to the left, creating a simple yet informative composition. The image appears to be a scan or a digital capture of a document or label.
ScoutPro Special 510(k) Premarket Notification
510(k) SUMMARY 1.
Name and Address of Sponsor:
NOV 1 9 2003
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
1028232
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
ScoutPro Class II (21 CFR 870.1250) Percutaneous Catheter DQY
General Description:
The ScoutPro 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 of the coronary sinus. The ScoutPro has been expanded and modified from BIOTRONIK's currently legally marketed SCOUT (K020821, 06-03-02). The following ScoutPro accessories are the subjects of this 510(K);
ScoutPro 8F that contains the following components:
- . 1 hemostatic valve
- . 2 guiding catheters BIO 1 and BIO 2
- 1 dilator for the quiding catheter .
- 1 peel-away sheath 11F
- 1 guide wire ●
- 1 needle .
- 1 svringe
- 2 slitter tools 4.9 F and 6.3 F for different lead sizes ●
ScoutPro Sheath "Hook" that contains the following components:
- . 1 quiding catheter "Hook"
- 1 dilator for the guiding catheter .
ScoutPro Sheath "Multi-Purpose Hook" that contains the following components:
- 1 guiding catheter "Multi-Purpose Hook" .
- 1 dilator for the guiding catheter .
ScoutPro Sheath "Amplatz 6.0" contains the following components:
- . 1 quiding catheter "Amplatz 6.0"
- . 1 dilator for the guiding catheter
Indication for Use:
The intended use of the ScoutPro is for introducing leads into the vessels of the left heart via the coronary sinus.
1
Name and Address of Manufacturers: BIOTRONIK GmbH & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers.
NOV 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BIOTRONIK, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035
Re: K033320 Trade Name: SCOUTPro Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: October 13, 2003 Received: October 15, 2003
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Mede May
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
l ﺴﺮ Page of
510(k) Number (if known):
Device Name:_SCOUTPro
Indications For Use:
The intended use of the SCOUTPro is for introducing leads into the vessels of the left heart via the coronary sinus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CMessis Mun for BDE
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) number K033202
(Optional Format 3-10-98)