TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

K033291 · Radi Medical Systems AB · QSY · Mar 17, 2004 · SU

Device Facts

• Record ID: K033291
• Device Name: TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
• Applicant: Radi Medical Systems AB
• Product Code: QSY · SU
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

TopSeal™ Hemostatic Dressing is a sterile, topical dressing impregnated with m.doc™ (calcium/sodium salt of micro-dispersed oxidized cellulose). The device functions as a hemostatic agent to promote topical bleeding control; it also serves as a bacterial barrier and is impermeable to water. It is intended for use in clinical settings to manage minor bleeding from wounds, lacerations, or percutaneous puncture sites. The dressing is applied topically by a healthcare provider to the bleeding site to facilitate hemostasis and protect the wound.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile dressing composed of an absorbent non-woven viscose-polyolefin layer impregnated with m.doc™ (calcium/sodium salt of micro-dispersed oxidized cellulose) and a non-adhesive non-woven polyester wound contact layer. Acts as a physical barrier and hemostatic agent.

Indications for Use

Indicated for control of minor bleeding from wounds, lacerations, or skin incisions/punctures following percutaneous medical procedures.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• FemoStop®HD (K024107)
• HemaDerm™ (K021678)
• Homosorb (K021581)

Submission Summary (Full Text)

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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, [e-mail].

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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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/

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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<br>Name:<br>Address: | Radi Medical Systems AB<br>Palmbladsgatan 10, SE-754 50<br>Uppsala, Sweden |
|-------------------------------------------------------|----------------------------------------------------------------------------|
| Phone/Fax:<br>Contact Person:<br>Date of Preparation: | + 46 18 16 10 00/ + 46 18 16 10 9<br>Helene Ekstrand<br>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.