(82 days)
Not Found
No
The summary describes a set of physical accessories for introducing leads and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as "accessories" for introducing leads, not providing a therapeutic effect itself.
No
The device is described as a system for introducing leads into the left heart, not for diagnosing a condition.
No
The device description lists multiple physical components (Hemostatic Valve, Guiding Catheters, Dilator, Introducer, Guidewire, Cannula, Syringe Body, Peel Tool), indicating it is a hardware-based medical device, not software-only.
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), not in vitro (outside the living body, typically on biological samples).
- Device Description: The components listed (catheters, guidewire, dilator, etc.) are all instruments used for accessing and navigating within the circulatory system during a medical procedure. They are not designed for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the SCOUT Accessories for Implanting in the Coronary Sinus are medical devices used for a surgical/interventional procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.
Product codes
DQX, DRB, DQY
Device Description
The SCOUT Accessories for Implanting in the Coronary Sinus are for introducing legally marketed leads into the vessels of the left heart via the coronary sinus. The following SCOUT Accessories for Implanting in the Coronary Sinus are the subject of this 510(k):
- 1 Hemostatic Valve .
- 2 Guiding Catheters Peel-Away (Long Sheaths) ●
- 1 Dilator (for Long Sheath) ●
- 1 Introducer Peel-Away 11F .
- . 1 - Guidewire
- 1 Cannula .
- . 1 - Syringe Body
- 1 Peel Tool ●
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.
Medtronic's LDS 6216 Left-Heart Delivery System (K012130, cleared 08-28-01)
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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JUN 0 3 2002
page 1 of 2
BIOTRONIK, Inc., SCOUT Accessories for Implanting in the Coronary Sinus, K020821 May 20, 2002
SCOUT Accessories for Implanting in the Coronary Sinus 510(k) K020821
510(K) SUMMARY 1.
Name and Address of Sponsor: BIOTRONIK, Inc.
6024 Jean Road Lake Oswego, OR 97035 1028232
Establishment Registration Number:
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
SCOUT Class II (21 CFR 870.1330; 21 CFR 870.1380) Wire, Guide, Catheter; Stylet, Catheters DQX, DRB
General Description:
The SCOUT Accessories for Implanting in the Coronary Sinus are for introducing legally marketed leads into the vessels of the left heart via the coronary sinus. The following SCOUT Accessories for Implanting in the Coronary Sinus are the subject of this 510(k):
- 1 Hemostatic Valve .
- 2 Guiding Catheters Peel-Away (Long Sheaths) ●
- 1 Dilator (for Long Sheath) ●
- 1 Introducer Peel-Away 11F .
- . 1 - Guidewire
- 1 Cannula .
- . 1 - Syringe Body
- 1 Peel Tool ●
The SCOUT Accessories for Implanting in the Coronary Sinus are functionally equivalent to marketreleased delivery systems. In specific, the materials used and design are similar to Medtronic's LDS 6216 Left-Heart Delivery System (K012130, cleared 08-28-01).
Indication for Use:
The intended use of the SCOUT Accessories for Implantation in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.
Name and Address of Manufacturer:
BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Requlatory Affairs Phone (888) 345-0374 ´ Fax (503) 635-9936
Name and Address of Contract Manufacturing Site:
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169
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K020821
Page 2 of 2
May 20, 2002
2. INDICATIONS FOR USE
The intended use of the SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.
See Appendix 1 for the 510(k) Indications for Use Form. Device description and substantial
3. PROPOSED LABELING
3.1 TECHNICAL MANUAL
The Technical Manual for the SCOUT Accessories is provided in Appendix 2.
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
BIOTRONIK, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035
Re: K020821
Trade Name: SCOUT Regulation Number: 21 CFR 870.1330, 870.1380, and 870.1250 Regulation Name: Wire, Guide, Catheter; Stylet, Catheter; Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQX, DRB, and DQY Dated: March 8, 2002 Received: March 13, 2002
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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.
Denise Tell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K020821 |
|---|---|
| Device Name: | SCOUT |
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Indications For Use:
The SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketedleads 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020821
(Optional Format 3-10-98)
Prescription Use X