(143 days)
Not Found
No
The summary describes a topical bandage for hemostasis and does not mention any AI or ML components or functionalities.
Yes.
The device's intended use is for the management of bleeding wounds to promote rapid control of bleeding, which constitutes a therapeutic effect.
No
Explanation: Chito-Seal is described as a topical bandage that promotes hemostasis for bleeding wounds. Its intended use is to manage bleeding, not to diagnose a condition or disease.
No
The device description clearly states "Chito-Seal is a topical bandage," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of bleeding wounds topically. This involves direct application to the body surface to control bleeding.
- Device Description: It's described as a "topical bandage" that promotes hemostasis when in contact with a bleeding wound. This is a physical interaction with the wound site.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. Chito-Seal is a therapeutic device applied directly to a wound.
N/A
Intended Use / Indications for Use
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
Chito-Seal is a topical bandage intended to promote hemostasis when in contact with a bleeding wound.
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)
Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of Chito-Seal.
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.
Marine Polymer Technologies SyvekPatch® (K984177)
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
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
Perclose Sevrina Ciucci Regulatory Affairs Coordinator 400 Saginaw Drive Redwood City, California 94063
Re: K021062 Trade/Device Name: Chito-Seal™ Regulatory Class: Unclassified Product Code: QSY
Dear Sevrina Ciucci:
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 August 23, 2002. 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.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 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 an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Ms. Sevrina Ciucci Regulatory Affairs Coordinator Perclose 400 Saginaw Drive Redwood City, California 94063
Re: K021062 Trade/Device Name: Chito-Seal™ Product Code: FRO Dated: July 9, 2002 Received: July 11, 2002
Dear Ms. Ciucci:
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, 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. Sevrina Ciucci
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
R. Mark N. Mulkerson
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
Confidential
VII. STATEMENT OF INDICATIONS FOR USE
510(k) Number:
Chito-Seal™
Device Name:
Indications for Use:
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.
Mark n. Mulkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO21062 510(k) Number _
4
Perclose, 510(k) K021062 Chito-Seal™ Amendment 02 Confidential
| 510(k) SUMMARY | AUG 2 3 2002 | |
|---|---|---|
| A. | Sponsor/Submitter: | Perclose |
| 400 Saginaw Drive | ||
| Redwood City, CA 94063 | ||
| Tel: (650) 474-3000 | ||
| Fax: (650) 474-3020 | ||
| B. | Contact Person: | Sevrina Ciucci |
| Regulatory Affairs Coordinator | ||
| (650) 474-3164 | ||
| C. | Date of Submission: | July 9, 2002 |
| D. | Trade (Brand) Name: | Chito-Seal™ |
| E. | Common Name: | Topical Hemostasis Pad |
| F. | Classification: | Unclassified Device |
| G. | Classification Name: | Dressing |
| H. | Product Code: | 79FRO |
| I. | Predicate Device: | Marine Polymer Technologies SyvekPatch® (K984177) |
J. Intended Use:
II.
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.
K. Device Description:
.
Chito-Seal is a topical bandage intended to promote hemostasis when in contact with a bleeding wound.
L. Summary of Substantial Equivalence:
Perclose has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Chito-Seal is substantially equivalent to currently marketed predicate device.
Chito-Seal has essentially the same intended use as the predicate device. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of Chito-Seal.
5
In conclusion, Chito-Seal has been shown to be substantially equivalent to the Class I predicate on which the device is based.
.
. .
:
: