(15 days)
Not Found
Not Found
No
The summary describes a mechanical hemostasis valve and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a hemostasis valve indicated for maintaining a seal and facilitating the introduction/withdrawal of devices, which suggests it is an accessory for medical procedures rather than a device intended to directly treat a disease or condition.
No
The device is described as a "Hemostasis Valve" used for maintaining a seal and flushing, which are procedural functions rather than diagnostic ones. It helps in the introduction/withdrawal of devices, but does not provide diagnostic information itself.
No
The device description and intended use clearly describe a physical medical device (Hemostasis Valve with Wire Guide) used for maintaining a seal and introducing/withdrawing interventional devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during a medical procedure (maintaining a seal around a lead terminal pin, flushing, introducing/withdrawing devices). This is an in vivo application, meaning it's used within a living organism.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and mechanical, not diagnostic.
N/A
Intended Use / Indications for Use
The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the IS-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
Product codes
DTL
Device Description
Not Found
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
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a stacked formation. The profiles are connected by a flowing line that resembles a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the top of the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Guidant Corporation c/o Ms. Colleen McCarter Bloom 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K031398
IS-1 Hemostasis Valve, Model 6799 Regulation Number: 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: May 2, 2003 Received: May 5, 2003
Dear Ms. McCarter Bloom:
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. Iisting 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.
1
Page 2 - Ms. Colleen McCarter Bloom
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2. INDICATIONS FOR USE STATEMENT
| 510(k) Number
| (If known) | |
|---|---|
| Device Name | IS-1 Hemostasis Valve |
| Indications for | |
| Use | The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal |
| around the IS-1 lead terminal pin while flushing the lead lumen and/or during | |
| introduction/withdrawal of interventional devices. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
XQeartu
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K03134
Hemostasis IS-1 Valve Special 510K Guidant Corporation May 2003