(116 days)
Indicated for Contrast Media Administration in Angiographic procedures.
The Dye Management® System is comprised of two (2) components namely; 1) a dye management set with contrast spikes. 2) A dye management set with in-line reservoir. The Dye Management® system is configured by attaching the reservoir set to either the one (1) or two (2) spike set.
The provided text describes a Special 510(k) submission for the ICU Medical Dye Management® System. This submission is for a medical device (catheter lab kit, angiography kit, dye management set) and not for an AI/ML powered device. As such, the specific criteria requested for AI/ML device studies (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, data provenance, etc.) are not applicable or mentioned in this type of submission.
Therefore, the response will focus on the information available in the provided text regarding device acceptance and the supporting study, while explicitly stating where AI/ML-specific information is not present.
Acceptance Criteria and Device Performance for ICU Medical Dye Management® System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Passed all acceptance criteria for the alternate Burette post-sterilization. | The alternate Burette has been tested post sterilization and passed all acceptance criteria. |
| Meets the functional claims as described in the product labeling. | The Dye Management System™ meets the functional claims. |
| Meets the intended use as described in the product labeling. | The Dye Management System™ meets the intended use. |
| Is safe and effective in terms of substantial equivalence to predicate sets. | The Dye Management System™ is safe and effective in terms of substantial equivalence. |
| Is indicated for Contrast Media Administration in Angiographic procedures. | The Dye Management® System is indicated for Contrast Media Administration in Angiographic procedures. |
Study Information (as applicable to a medical device submission, not AI/ML):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for an explicit "test set" in the context of clinical data for AI/ML. The testing mentioned refers to device component integrity (alternate burette). No information on data provenance (country, retrospective/prospective) is provided, as this is not a study involving clinical data for algorithmic performance.
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)
- Not applicable. This is a submission for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple readers for diagnostic accuracy, which is not the focus of this device submission.
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
- Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device. No standalone algorithmic performance is relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is based on engineering and manufacturing specifications and functional testing of the device components (specifically, the alternate burette) and comparison to established predicate devices. It is not clinical ground truth in the sense of diagnostic accuracy.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set involved for this device.
9. How the ground truth for the training set was established
- Not applicable. No AI/ML training set.
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K06 3784 page 1 of 2
APR 1 6 2007
ICU Medical, Inc. - Dye Management® System Special 510(k) / December 2006
Special 510(k) Summary
Name of Submitter: ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123
Manufacturer and Establishment Registration Number:
| Manufacturer: | Sterilization Sites: |
|---|---|
| ICU Medical (Utah), Inc | Sterigenics US, Inc - Utah |
| 4455 Atherton Drive | 5725 West Harold Gatty Drive |
| Salt Lake City, Utah 84123 | Salt Lake City, Utah 84116 |
| Site Registration Number: 1713468 | Site Registration Number: 1721676 |
| Or | |
| N/A | Steris Isomedix |
| 7685 St. Andrews Ave | |
| San Diego, California 92154 | |
| Site Registration Number: 2032112 |
Proprietary or Trade Name of Proposed Device: The ICU Medical Dye Management® System.
Common Name: Catheter lab kit, angiography kit, dye management set.
Device Classification, Pancode and ProCode: Class II, 74 - DQO
Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Diagnostic Intravascular Catheters. Dye Management® sets are regulated within 21 CFR 870.1200.
Intended Use / Indications for Use: Indicated for Contrast Media Administration in Angiographic procedures.
Proposed Device Description: The Dye Management® System is comprised of two (2) components namely; 1) a dye management set with contrast spikes. 2) A dye management set with in-line reservoir. The Dye Management® system is configured by attaching the reservoir set to either the one (1) or two (2) spike set.
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K063784 page 2 of 2
ICU Medical, Inc. - Dye Management® System Special 510(k) / December 2006
Summary of Substantial Equivalence:
Similarities:
-
- The current and proposed sets have the same intended use
-
- The current and proposed sets are assembled for customer convenience using currently manufactured components.
-
- The current and proposed sets contain the same type of components.
Differences:
-
- An alternate burette, made of different materials and construction, is being added for use in the assembly of this set.
Statement of Safety and Effectiveness:
The alternate Burette has been tested post sterilization and passed all acceptance criteria. The Dye Management System™ meets the functional claims and intended use as described in the product labeling and is safe and effective in terms of substantial equivalence as the predicate set(s) described in this document.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. To the left of the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2007
ICU Medical, Inc. c/o Mr. Martin Maier Senior QA Engineer 4455 Atherton Dr. Salt Lake City, UT 84123
Re: K063784
Dye Management System™M Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: March 15, 2007 Received: March 19, 2007
Dear Mr. Maier:
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 Act. The Act. The A 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. Martin Maier
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 vours.
una R. Vulnes
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
0(k) Number (if known): _____________________________________________________________________________________________________________________________________________________
avice Name: Dye Management System™
ications for Use: The Dye Management® System is indicated for Contrast Media Administration in giographic procedures.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Holmes
Division Sign-Off) Division of Cardiovascular Devices
:10(k) Number_KO63784
Page 1 of 1
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).