(16 days)
The UltimumTM EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
The UltimumTM EV (14F-22F) Hemostasis Introducers are introducers designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site. The introducers include a sheath, hub, hemostasis valve, sideport for 3-way stopcock, radiopaque tip marker, and dilator. The introducers are provided sterile, and are intended for single-use only.
The provided text describes a 510(k) premarket notification for the "Ultimum™ EV Hemostasis Introducer." This is a medical device designed for introducing catheters and electrodes into a vessel while minimizing blood loss. The submission aims to establish substantial equivalence to a predicate device.
However, the document does not contain the detailed information required to answer the questions about acceptance criteria and a study proving device performance in the typical sense of an AI/ML device study.
Here's why and what information we can extract:
- Device Type: This is a physical medical device (catheter introducer), not an AI/ML software device. Therefore, the questions about "test set," "training set," "ground truth," "number of experts," "adjudication," and "MRMC comparative effectiveness study" are not applicable in their usual context for AI/ML.
- Study Type: The submission focuses on confirmatory testing to demonstrate substantial equivalence to an existing predicate device, not on clinical effectiveness studies with human readers or AI algorithms.
Given this, I will answer the questions based on the type of information typically provided for this kind of physical device submission where applicable, and explicitly state when the requested information is not present or not relevant to this type of device.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance:
The document states that "Confirmatory testing included tensile testing, flexure testing, hemostasis seal testing and visibility testing comparing competitor devices." It also explicitly mentions that "All technological characteristics of the Ultimum™ EV Hemostasis Introducers are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling."
While specific numerical acceptance criteria (e.g., "hemostasis seal must withstand X pressure") and precise reported performance metrics are not provided in this 510(k) summary, the overall acceptance criterion is:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device in: | The Ultimum™ EV Hemostasis Introducer is considered substantially equivalent to the predicate device. |
| - Product design | Meets criteria for product design. |
| - Packaging | Meets criteria for packaging. |
| - Sterilization | Meets criteria for sterilization. |
| - Labeling | Meets criteria for labeling. |
| Confirmatory Testing results for: | |
| - Tensile strength | Performance is comparable to (and implicitly meets or exceeds) competitor devices and predicate. |
| - Flexure strength | Performance is comparable to (and implicitly meets or exceeds) competitor devices and predicate. |
| - Hemostasis seal | Performance is comparable to (and implicitly meets or exceeds) competitor devices and predicate. |
| - Visibility | Performance is comparable to (and implicitly meets or exceeds) competitor devices and predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample sizes (e.g., number of units tested) for the tensile, flexure, hemostasis seal, or visibility testing.
- Data Provenance: Not explicitly stated, but given it's a submission by St. Jude Medical, Daig Division, based in Minnetonka, Minnesota, U.S.A., it's highly probable the testing was conducted in the U.S. and is prospective for the purpose of this submission (i.e., tests were conducted for this submission, rather than re-analyzing existing data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This question is not applicable to this type of device and study. "Ground truth" in the context of physical device testing refers to the objective physical measurements obtained from the confirmatory tests (tensile, flexure, hemostasis seal, visibility). These are not established by human expert consensus or interpretation in the way an AI/ML diagnostic device's ground truth would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, typically for diagnostic image review. For physical device testing, physical measurements are largely objective and do not require this type of adjudication.
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:
This question is not applicable. The device is a physical catheter introducer, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable. This is a physical medical device, not an algorithm, so a standalone performance assessment of an algorithm is irrelevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for the confirmatory testing (tensile, flexure, hemostasis seal, visibility) would be the objective physical measurements and engineering specifications obtained from standardized testing protocols. These are not derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This question is not applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of this 510(k) submission. Design and manufacturing processes are refined through product development, but this is not typically referred to as a "training set" in the AI sense.
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated above.
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B.
510(k) Summary (As required by 21 CFR 807.92)
A. Submitter Information
OCT 31 2002
| Submitter's Name: | St. Jude Medical, Daig Division |
|---|---|
| Address: | 14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | (952) 238-9356 |
| Contact Person: | Glenn Jacques |
| Date Submission Prepared: | October 11, 2002 |
| Device Information | |
| Common or Usual Name: | UltimumTM EV Hemostasis Introducer |
| Classification Name: | Catheter Introducer |
| Predicate Device: | UltimumTM EV Hemostasis IntroducerSt. Jude Medical, Daig Division |
| Device Description: | The UltimumTM EV (14F-22F) Hemostasis Introducersare introducers designed to provide easy access to thevascular system while providing convenient temporaryclosure of a standard indwelling introducer access site.The introducers include a sheath, hub, hemostasis valve,sideport for 3-way stopcock, radiopaque tip marker, anddilator. The introducers are provided sterile, and areintended for single-use only. |
| Intended Use: | The UltimumTM EV Hemostasis Introducers are designedfor the introduction of angiographic catheters, closed endcatheters, balloon catheters and electrodes into a vesselwhere minimizing blood loss is essential. |
Comparison of Required Technological Characteristics C.
All technological characteristics of the Ultimum™ EV Hemostasis Introducers are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling.
Support of the Substantial Equivalence D.
St. Jude Medical, Daig Division considers the Ultimum™ EV Hemostasis Introducer, 22F, to be substantially equivalent to the predicate device, Ultimum™ EV Hemostasis Introducers which received marketing clearance January 3, 2001 (K003729) Confirmatory testing included tensile testing, flexure testing, hemostasis seal testing and visibility testing comparing competitor devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Specialist Daig Division 14901 DeVeau Place Minnetonka, MN 55345
Re: K023447
Trade Name: Ultimum™ EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 11, 2002 Received: October 15, 2002
Dear Mr. Jacques:
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. Glenn Jacques
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 vour 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,
Dalton
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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Page
510(k) Number (if known):
KO2344
Ultimum™ EV Hemostasis Introducer Device Name:
Indications for Use:
The Ultimum™ EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
(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 K023447
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).