(110 days)
IVA Seal II
Not Found
No
The device description and intended use clearly define a physical seal with no mention of software, data processing, or any AI/ML related terms.
No
The device is a tamper-evident seal for drug containers, not a device used to treat or diagnose a medical condition in a patient. Its function is to protect the integrity of the drug container, not directly therapeutic.
No
The device is described as a tamper-evident, sterile seal for containers, which serves to protect the septum surface and indicate tampering. Its function is not related to diagnosing any medical condition or disease.
No
The device description clearly states it is a "seal used to cover and protect the septum surface," indicating a physical, hardware-based device. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover and protect the septum surface of drug containers and provide a tamper-evident seal. This is a physical barrier and security function related to drug handling, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the physical properties of the seal and its tamper-resistant function. It does not mention any interaction with biological samples or diagnostic procedures.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The device is clearly intended for use in a pharmacy setting to ensure the integrity and security of drug containers. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
Product codes (comma separated list FDA assigned to the subject device)
KPE
Device Description
The device is a seal used to cover and protect the septum surface of a previously opened vial, IV bottle or bag. The seal serves as a tamper resistant seal in that, once the seal; is removed, it can not be reattached to the septum.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IVA Seal II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).
0
K974180C
510(K) SUMMARY (as required by 807.92(c))
FEB 24 1998
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)
3234 Ella Lane
New Port Richey, Florida 34655 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Phone: | 813-376-4154 |
| Fax: | 813-376-7186 |
| Contact Person: | Ed Ransom |
| Date of Summary: | November 3, 1997 |
| Trade Name: | Steri-Tamp |
| Classification Name: | Seal, adhesive, accessory to IV container |
| Predicate Device: | IVA Seal II |
| Device Description/Comparison: | The device is a seal used to cover and protect the septum
surface of a previously opened vial, IV bottle or bag. The
seal serves as a tamper resistant seal in that, once the seal;
is removed, it can not be reattached to the septum. |
| Pharmacy, Inc. | U.S. Clinical Products | |
|---|---|---|
| Materials: Top Layer | Metalized Polyester | Metal |
| Bottom Layer | Polypropylene | Metal |
| Packaging: | Roll Stock on 3" core in a dispenser box | Same |
| Seals per roll | 1000 | Same |
| Dispenser Box | Sealed in a vented polypropylene bag | Same |
| Sterilization | ETO | Gamma Radiation |
| Reattach | Can not be reattached | Same |
| Coding | Multi-color | Same |
| Tampering | Tamper evident | Same |
| Removal | Pull Tab | Same |
The product is a tamper evident, sterile seal used to cover Intended Use: opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Mr. Ed Ransom President Pharmacy, Incorporated Fiarmacy) incorporary & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655
K974180 Re : Steri-Tamp Trade Name: Requlatory Class: II Product Code: KPE Dated: February 4, 1998 February 6, 1998 Received:
Dear Mr. Ransom: :
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895, ... A........................................................................................................................ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition; FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
2
Page 2 - Mr. Ransom
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of . Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runner
by Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): __
STERI-TAMP Device Name:
Indications For Use:
The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
. .
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pattraux Accenite
(Division Sign Off)
Division of Dental, Infection Control, and General Hospital Decil
510(k) Number 1974180
Prescription Use (Per 21 CFR 801.109)
.. .
OR
Over-The-Counter Use ✓
(Optional Format 1-2-96)