(72 days)
The HOSPIRA CathLab Convenience Kits are intended for use in cardiac catheterization and radiology procedures requiring the use of contrast media. These procedures include right heart studies, venogram and arteriogram. The kit provides the user with a "ready-to-use" set up avoiding the need to acquire / assemble components from various manufacturers. The kit is intended for one-time use.
The intended use of the antiseptic contained within a kit is to prepare the patient's skin prior to surgery.
The HOSPIRA CathLab Convenience Kits are comprised of variations of the following components: Needles, guide wires, vessel dilators, slide clamps, suture wings, suture wing clips, syringes, table covers, stopcocks, absorbent towels, gauze sponges, Lidocaine HCl injection, drapes, scalpels, silk cutting needle suture, dressings and sharps stick pads.
The provided text describes a Special 510(k) submission for HOSPIRA CathLab Convenience Kits. This is a premarket notification to the FDA for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of a novel device based on specific acceptance criteria.
The primary goal of this submission is to demonstrate that the modified device (HOSPIRA CathLab Convenience Kits with an alternate antiseptic) is as safe and effective as existing, legally marketed predicate devices. This type of submission relies on demonstrating similarities and justifying differences, rather than providing extensive performance data against predefined acceptance criteria for a new feature's clinical efficacy.
Therefore, many of the requested details about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies are not applicable or explicitly provided within this type of regulatory document.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a Special 510(k) for a convenience kit with a new antiseptic, the "acceptance criteria" primarily relate to the safety and functionality of the new component (ChloraPrep® antiseptic applicator) and the overall kit's continued substantial equivalence.
| Acceptance Criteria (Implied for the new antiseptic) | Reported Device Performance |
|---|---|
| Maintain material integrity after sterilization | ChloraPrep® applicator passed all test criteria after three EtO cycles. |
| Functionality as intended for antiseptic application | ChloraPrep® applicator passed all test criteria after three EtO cycles. |
| Overall kit retains substantial equivalence to predicate device (composition, intended use) | "The HOSPIRA CathLab Convenience Kits meet all functional claims and intended use... in terms of substantial equivalence as the predicate convenience kit(s)." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions the ChloraPrep® applicator was "tested," but the number of units tested is not provided.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer (Hospira or its suppliers) for regulatory submission purposes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable / Not provided. The "ground truth" here is the pass/fail result of specific engineering or compatibility tests for the antiseptic applicator, not a clinical assessment requiring expert interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. Adjudication typically applies to expert review of clinical data. For engineering tests, results are usually objective (e.g., material integrity, sterility testing which would be performed by lab personnel).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for a convenience kit and the addition of an antiseptic applicator. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not the scope of this device or regulatory submission.
6. Standalone Performance (Algorithm only without human-in-the-loop):
- Not applicable. This device is a collection of medical components, not an algorithm or AI system.
7. Type of Ground Truth Used:
- Engineering/Material Testing Results and Functional Performance: The "ground truth" for the new antiseptic applicator appears to be its ability to withstand sterilization and maintain its functional properties, as determined by laboratory tests. For the overall kit, the "ground truth" is its composition maintaining the same intended use attributes as the predicate device(s).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The "testing" refers to verification and validation of manufacturing processes and component compatibility.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML model, this question does not apply.
In summary, this document is a regulatory submission for a minor modification to an existing medical device, focusing on demonstrating substantial equivalence rather than presenting clinical efficacy data or advanced AI performance metrics.
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HOSPIRA CathLab Convenience Kits· *
Special 510(k) / October 2005
DEC 2 2 2005
Special 510(k) Summary
Hospira, Incorporated Name of Submitter: 275 North Field Drive Lake Forest, Illinois 60045 Owner/Operator #: 9063339
Manufacturer and Establishment Registration Number:
| Manufacturer: | Sterilization Site: |
|---|---|
| ICU MEDICAL (UTAH), INC. | Sterigenics US, INC – Utah5725 West Harold Gatty DriveSalt Lake City, UT 84116Establishment Registration #: 1721676 |
| 4455 Atherton Dr. | |
| Salt Lake City, UT 84123 | OR |
| Establishment Registration #: 1713468 | Sterigenics US, INC – NM2400 Airport RoadSanta Teresa, NM 88008Establishment Registration #: 1721686 |
Proprietary or Trade Name of Proposed Device: HOSPIRA CathLab Convenience Kits
CathLab Kit / Convenience Kit, Diagnostic Intravascular Catheter. Common Name:
Device Classification, Pancode and ProCode: Class II, 74 - DQO
Performance Standards: No performance standards have been established under Section 514 of the Food, Ferror mance Standards. No performance station of any of the ence regulated within 21 CFR 870.1200.
Intended Use / Indications for Use:
Intended USe / Indications for USE.
The HOSPIRA CathLab Convenience Kits are intended for use in cardiac catheterization and radiology The HUSFIRA CanLao Convenience Kits are media. These procedures include right heart studies, venogram and procedures requiring the use of contrast media." Theosephise" set up avoiding the need to acquire / assemble arterrogients from various manufacturers. The kit is intended for one-time use.
The intended use of the antiseptic contained within a kit is to prepare the patient's skin prior to surgery.
Proposed Device Description:
The HOSPIRA CathLab Convenience Kits are comprised of variations of the following components: Needles, guide wires, vessel dilators, slide clamps, suture wings, sunure wing clips, syninges, able covers, Nections, guide wires, vesser chaters, absorbent towels, gauze sponges, Lidocaine HCl injection, drapes, scalpels, silk cutting needle suture, dressings and sharps stick pads.
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Special 510(k) / October 2005
Summary of Substantial Equivalence
Summary of Substantial Equivalence
The HOSPIRA CathLab Convenience Kits as described in this substantialy equivalent to the securities The HUSFIRA CauliLab Collivelier Itis as deciritor and the following characteristics:
Similarities:
-
- Both kits have the same intended use.
- IT) Both kits have the same mended use.
- Both kits are assembled for customer convenience using currently manufactured components.
-
- Both kits contain the same types of components.
Differences:
-
- An alternate antiseptic, ChloraPrep® antiseptic, is being added for use in the assembly of this a convenience kit.
Statement of Safety and Effectiveness
The ChloraPrep® applicator has been tested after three EtO cycles and has passed all test criteria. The The Chorarrep® applicator has been tested the functional claims and intended use as described in the ITOSI INA Caulfad Conventule Itis most in terms of substantial equivalence as the predicate convenience kit(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 & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
ICU Medical, Inc. c/o Thomas Kozma, Ph.D. Associate Director, Global Regulatory Affairs 4455 Atherton Dr. Salt Lake City, UT 84123
Re: K052865 HOSPIRA Cath Lab Convenience Kits Regulation Number: 21 CFR 870.1200 Regulation Name: Diagno0stic intravascular catheter Regulatory Class: II Product Code: DQO Dated: November 21, 2005 Received: November 22, 2005
Dear Dr. Kozma:
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 -- Thomas Kozma, Ph.D.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duma R. lo Miner
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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510(k) Number (if known) に 05 2 86 5
HOSPIRA Cath Lab Convenience Kits Device Name:
Indications for Use:
The HOSPIRA Cath Lab Convenience Kits are intended for use in cardiac catheterization and radiology procedures requiring the use of contrast media. These procedures include right heart studies, venogram and arteriogram. The kit provides the user with a "ready-to-use" set up avoiding the need to acquire / assemble components from various manufacturers. The kit is intended for one-time use.
Prescription Use × -(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Viener
Caluruvas 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
510(k) Numbe Ko52865
§ 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).