(155 days)
Not Found
No
The summary describes a passive hemostatic dressing with no mention of AI or ML components or functions.
No
The device is a hemostatic dressing intended for superficial wound care, aimed at controlling minor bleeding rather than treating a disease or condition for therapeutic benefit.
No
The device description and intended use indicate that TopSeal™ Hemostatic Dressing is used for controlling bleeding, not for diagnosing a medical condition.
No
The device description clearly states it is a sterile dressing impregnated with a hemostatic agent, which is a physical product, not software.
Based on the provided information, the TopSeal™ Hemostatic Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- TopSeal™ Function: The description clearly states that TopSeal™ is a "sterile dressing impregnated with a hemostatic agent" used for "control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures." It is applied topically to the wound site.
- No Sample Analysis: The device does not involve the analysis of any biological samples taken from the body. Its action is directly on the external wound.
Therefore, TopSeal™ Hemostatic Dressing falls under the category of a medical device used for wound management and hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.
Product codes
QSY, FRO
Device Description
TopSeal™ Hemostatic Dressing is a sterile dressing imprognated with the hemostatic agent m.doc™ (calcium/sodium salt of micro-dispersod oxidized cellulose). The active hemostatic agent promotes the topical control of blocding.
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)
FcmoStop®HD (K024107), HemaDerm™ (K021678), Homosorb (K021581)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2023
RADI Medical Systems AB Helene Ekstrand Regulatory Affairs Officer Palmbladsgatan 10 SE-754 50 Uppsala Sweden
Re: K033291 Trade/Device Name: TopSeal™ Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Helene Ekstrand:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 17, 2004. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/7 description: The image shows the closing of a letter, including the sender's name and title. The letter is signed by Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works in OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized wing shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Ms. Helene Ekstrand Regulatory Affairs Officer RADI Medical Systems AB Palmbladsgatan 10 SE-754 50 Uppsala. Sweden
Re: K033291
Trade/Device Name: TopSeal™ Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 14, 2004 Received: January 16, 2004
Dear Ms. Ekstrand:
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 markcted 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.
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.
2
Page 2 - Ms. Helene Ekstrand
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) 594-4659. 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K033291
Device Name: TopSeal™ Hemostatic Dressing.
Indications For Use: TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number___Ko 3329/
4
K03329
MAR 1 7 2004
510(k) SUMMARY 9.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and CFR 21 § 807.92
| Submitter's Information
Name:
Address: | Radi Medical Systems AB
Palmbladsgatan 10, SE-754 50
Uppsala, Sweden |
|-------------------------------------------------------|----------------------------------------------------------------------------|
| Phone/Fax:
Contact Person:
Date of Preparation: | + 46 18 16 10 00/ + 46 18 16 10 9
Helene Ekstrand
October 10th, 2003 |
Device Name:
Trade name: Common name: Regulatory Class Product Code:
Predicate Device Names:
TopSeal™ Hemostatic Dressing Dressing Unclassified FRO
FcmoStop®HD (K024107) HemaDerm™ (K021678) Homosorb (K021581)
Device Description:
TopScal™ Hemostatic Dressing is a sterile dressing imprognated with the hemostatic agent m.docTM (calcium/sodium salt of micro-dispersod oxidized cellulose). The active hemostatic agent promotes the topical control of blocding.
agent promotes the topheat comes as a so impermeable to water and acts as a bacterial barner.
Indication for Use:
moreation for Use.
TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and Topocal - Fremockens trom skin incisions or punctures following percutaneous medical procedures.
Technical Characteristics Summary:
Technical Cital acteristics Summary.
TopScal™ Homostatic Dressing is a sterile dressing is identical to the homostatic dressing Toporated into the FemoStop@HD Femoral Compression System. The pad is made of absorbent, non-woven, viscose-polyoletin layer, impregnated with a hemostatic agent (calcium/sodium salt of micro-dispersed oxidized cellulose) and covered with a non-adhesive, non-woven polyester wound contact layer.