(82 days)
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.
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 ●
Here's an analysis of the provided text regarding theacceptance criteria and substantiating study for the BIOTRONIK SCOUT Accessories:
The provided documents (K020821) describe a 510(k) submission for the BIOTRONIK SCOUT Accessories for Implanting in the Coronary Sinus. This submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way one might expect for a novel or high-risk device.
Therefore, the information you've requested regarding acceptance criteria and a detailed study proving the device meets those criteria is largely absent from these documents because the regulatory pathway chosen (510(k)) relies on demonstrating equivalence rather than comprehensive standalone performance testing against pre-defined quantitative criteria.
However, I can extract the relevant information and fill in the blanks where the document explicitly states the approach.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The SCOUT Accessories must be functionally equivalent to legally marketed delivery systems for introducing leads into the left heart via the coronary sinus. This implies demonstrating similar performance characteristics (e.g., ability to introduce leads, material compatibility, safety profile) without necessarily quantifying specific metrics beyond those of the predicate. | The SCOUT Accessories for Implanting in the Coronary Sinus are stated to be "functionally equivalent to market-released delivery systems." Specifically, "the materials used and design are similar to Medtronic's LDS 6216 Left-Heart Delivery System (K012130, cleared 08-28-01)." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. In a 510(k) submission based on substantial equivalence, the "test set" is often implicit in the comparison to the predicate device's design and materials, rather than a dedicated clinical trial or large-scale performance study. If any testing was done beyond comparison, the specific "sample size" for such tests is not detailed here.
- Data Provenance: Not explicitly stated as "retrospective" or "prospective" clinical data. The primary "data" for substantial equivalence is the comparison to the predicate device's design, materials, and intended use, which are established and legally marketed. Compliance with manufacturing (Quality Systems Regulation) is mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The regulatory approach here does not involve establishing "ground truth" for a test set in the sense of clinical annotations or diagnostic accuracy, but rather validating design and functional similarity to a predicate device. The experts involved would likely be internal engineers and regulatory affairs personnel from BIOTRONIK, and later, FDA reviewers.
-
Adjudication method for the test set:
- Not Applicable. As no specific "test set" in the context of clinical evaluation or diagnostic performance is described, no adjudication method would be reported.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a medical device for lead delivery, not an AI/diagnostic imaging device. Therefore, MRMC studies and AI-assisted improvements are not relevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device for lead delivery, not an algorithm.
-
The type of ground truth used:
- The "ground truth" in this context is the safety and effectiveness of the predicate device (Medtronic's LDS 6216 Left-Heart Delivery System, K012130) as having been legally marketed and cleared by the FDA. The SCOUT Accessories aim to demonstrate equivalence to this established "truth." The "evidence" typically involves bench testing, material comparisons, and adherence to relevant standards to show the new device performs as intended and is as safe and effective as the predicate.
-
The sample size for the training set:
- Not Applicable. This is a hardware medical device; no "training set" in the machine learning sense is relevant.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 7).
Summary of the Regulatory Approach:
The provided documents clearly indicate a 510(k) pathway for the SCOUT Accessories. This means the primary "study" performed is an extensive comparison to a predicate device (Medtronic's LDS 6216 Left-Heart Delivery System). The "acceptance criteria" revolve around demonstrating that the new device shares similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness when compared to the predicate. This typically involves:
- Comparison of Intended Use: Identical or very similar uses.
- Comparison of Technological Characteristics: Similar materials, design, operating principles.
- Performance Data: Often bench testing, material testing, and biocompatibility, but not necessarily de novo clinical trials with large patient cohorts and complex statistical analyses, unless a significant difference from the predicate is identified.
The absence of detailed clinical study data with specific patient sample sizes, expert panels, and statistical endpoints is typical for a 510(k) submission where substantial equivalence is the goal. The FDA's clearance (JUN 03 2002) signifies that the agency accepted this comparison and deemed the device substantially equivalent to the predicate.
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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.
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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
§ 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.