(72 days)
Not Found
Not Found
No
The device description lists standard medical supplies and the intended use is for convenience in procedures. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device provides a ready-to-use kit for procedures where contrast media is used, and it helps prepare the patient's skin for surgery, but does not directly treat a disease or condition.
No
The primary function of the device is to provide a "ready-to-use" kit for cardiac catheterization and radiology procedures that utilize contrast media. These procedures are typically interventional or preparatory for treatment, rather than directly diagnosing a condition based on the kit's components. The mention of "right heart studies, venogram and arteriogram" refers to the procedures the kit is used for, not an inherent diagnostic capability of the kit itself. The kit facilitates these procedures but does not, for example, analyze patient data or capture diagnostic images.
No
The device description explicitly lists numerous hardware components such as needles, guide wires, syringes, and scalpels, indicating it is a kit of physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cardiac catheterization and radiology procedures requiring contrast media, and for preparing the patient's skin prior to surgery. These are procedures performed on the patient, not on a sample taken from the patient to diagnose a condition.
- Device Description: The components listed are instruments and supplies used directly in medical procedures on a patient (needles, guide wires, syringes, scalpels, dressings, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 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.
Product codes
DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 – Utah |
| 5725 West Harold Gatty Drive | |
| Salt Lake City, UT 84116 | |
| Establishment Registration #: 1721676 | |
| 4455 Atherton Dr. | |
| Salt Lake City, UT 84123 | OR |
| Establishment Registration #: 1713468 | Sterigenics US, INC – NM |
| 2400 Airport Road | |
| Santa Teresa, NM 88008 | |
| Establishment 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.
1
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.
2
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.
3
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
4
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