(27 days)
The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
The provided text contains information about a 510(k) submission for a medical device (Modified Acumen Lead Delivery Sheath). However, it does not include information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or MRMC studies) typically found in a clinical or performance study report.
The document primarily focuses on regulatory aspects, such as:
- Device Description: A single-use percutaneous catheter to introduce pacing/defibrillator leads.
- Intended Use: Introduction of various types of pacing or defibrillator leads and catheters.
- Predicate Device: Acumen Lead Delivery Sheath (K051515).
- Materials: Stated as suitable and used in previously cleared products.
- Testing: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This statement indicates that testing was done and met specifications, but it does not provide the acceptance criteria or the specific results of those tests.
- Substantial Equivalence: Claimed based on identical or substantially equivalent intended use, method of operation, construction, and materials to the predicate device.
Therefore, I cannot populate the requested table or answer most of the detailed questions about acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- N/A: This information is not explicitly stated in the provided text. The document only mentions "all components, subassemblies, and/or full devices met the required specifications for the completed tests," without detailing what those specifications or results were.
2. Sample size used for the test set and the data provenance
- N/A: The document does not describe a clinical test set or details about data provenance. The testing mentioned is likely bench testing for design verification, not a clinical study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: No ground truth establishment is described, as there's no mention of a clinical test set requiring expert interpretation.
4. Adjudication method for the test set
- N/A: Not applicable, as no test set requiring adjudication is described.
5. 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
- N/A: This device is a physical medical instrument (catheter sheath), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: Not applicable, as no ground truth for "testing" in the context of diagnostic performance is described. The "testing" referred to in the document is likely engineering/bench testing (e.g., tensile strength, flexibility, biocompatibility, etc.) that would have defined specifications, but these are not provided.
8. The sample size for the training set
- N/A: Not applicable, as this is a physical device, not an AI model or a device requiring a training set in that context.
9. How the ground truth for the training set was established
- N/A: Not applicable, for the same reason as above.
In summary, the provided K062145 document is a regulatory submission for premarket notification (510(k)) asserting substantial equivalence, not a detailed performance study report. It confirms that "appropriate testing has been performed and all components... met the required specifications," but does not disclose those specifications or the detailed results.
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AUG 2 3 2006
5. 510(k) Summary General Information
Date Compiled
Classification
Trade Name
Submitter
July 26, 2006 Class II
Orion 11
Modified Acumen Lead Delivery Sheath
Models: LDS-10-57, LDS-10-64, LDS-10-57-90, and LDS-10-64-90
Acumen Medical, Inc. 275 Santa Ana Court Sunnyvale, CA 94085
Tel: 408-530-1810 Fax: 408-530-1811
Contact
Marybeth Gamber Director, Regulatory Affairs
Intended Use
The Modified Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters ..
Predicate Devices
Acumen Lead Delivery Sheath Manufactured by Acumen Medical, Inc. K051515
Device Description
The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.
Matcrials
All materials used in the manufacture of the Modified Acumen LDS are suitable for this use and have been used in numerous previously cleared products.
Testing
Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
Acumen Medical, Inc. believes the Modified Acumen Lead Delivery Sheath is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are cither identical or substantially equivalent to existing legally marketed predicate product.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2006
Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085
Re: K062145
Trade/Device Name: Modified Acumen Lead Delivery Sheath Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. Marybeth Gamber:
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 - Ms. Marybeth Gamber
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/Summner for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.
This application 510(k) Number (if known):
Device Namc: Modified Acumen Lead Delivery Sheath
Indications for Use:
.
The Acumen Lead Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Prescription Use _X (Pcr 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Pcr 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummina
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060145
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).