(110 days)
The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
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.
This document is a 510(k) premarket notification for the Steri-Tamp device, which is a tamper-evident, sterile seal for drug containers. The provided text is a regulatory submission to the FDA and does not contain a study proving that the device meets acceptance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.
The "study" here is essentially a comparison to a predicate device to establish substantial equivalence, which is the basis for 510(k) clearance. The acceptance criteria are implicit in the comparison to an already legally marketed device (IVA Seal II).
Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of your detailed questions because the document is a regulatory submission for a simple medical accessory, not a clinical study report.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implied to be "substantially equivalent" to the predicate device, IVA Seal II, in terms of materials, packaging, seals per roll, dispenser box, sterilization, reattach characteristic, coding, tampering evidence, and removal method. The performance is presented as direct comparison.
| Feature / Acceptance Criteria (Implicit: "Same as predicate") | Predicate Device (IVA Seal II) Performance | Steri-Tamp Device Performance |
|---|---|---|
| Materials: Top Layer | Metal | Metalized Polyester |
| Materials: Bottom Layer | Metal | Polypropylene |
| Packaging | Roll Stock on 3" core in a dispenser box | Roll Stock on 3" core in a dispenser box |
| Seals per roll | 1000 | 1000 |
| Dispenser Box | Sealed in a vented polypropylene bag | Sealed in a vented polypropylene bag |
| Sterilization | Gamma Radiation | ETO (Ethylene Oxide) |
| Reattach | Can not be reattached | Can not be reattached |
| Coding | Same (Implicit: Multi-color as described for Steri-Tamp) | Multi-color |
| Tampering | Tamper evident | Tamper evident |
| Removal | Pull Tab | Pull Tab |
Note on Differences: While metalized polyester and polypropylene for the top and bottom layers, respectively, and ETO sterilization are different from the predicate device's materials and sterilization method (metal for both layers, Gamma Radiation), the FDA's clearance indicates these differences were not considered to raise new questions of safety or effectiveness and therefore were deemed substantially equivalent. The key functional characteristics (e.g., tamper-evidence, inability to reattach, sterility) are preserved.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a clinical study with a "test set" in the traditional sense. It's a device comparison.
- Data Provenance: Not applicable.
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. Ground truth for a clinical study is not relevant here. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 device is a simple sterile seal, not an AI-powered diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this regulatory submission is the predicate device's previously established safety and effectiveness. The argument is that Steri-Tamp is substantially equivalent to the predicate.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
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K974180C
510(K) SUMMARY (as required by 807.92(c))
FEB 24 1998
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)3234 Ella LaneNew 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 septumsurface of a previously opened vial, IV bottle or bag. Theseal 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.
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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
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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
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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)
§ 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).