(28 days)
The ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the Biotronik, Inc. ScoutPro ACS CS Lead Introducer System. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use.
Crucially, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria. It is a regulatory clearance letter, not a scientific study report.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as an FDA clearance stating that the device is "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices. The detailed performance data and acceptance criteria would have been part of the 510(k) submission that led to this clearance letter, but are not included in the letter itself.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 23 2010
Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035
Re: K101776
Trade/Device Name: ScoutPro ACS CS Lead Introducer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, DRE, DQX Dated: June 24, 2010 Received: June 25, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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Page 2 – Mr. Jon Brumbaugh
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
for
E
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number: K101776
Device Name: ScoutPro ACS CS Lead Introducer System
Indications For Use:
The ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z.J.S.M.
Division of Cardiovascular Devices
510/k) Numbe
§ 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).