(191 days)
Not Found
No
The device description and intended use focus on a physical dressing with an adhesive and a valve. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "occlusive wound dressing" and "temporary bandage to treat penetrating chest wounds". It functions as a medical device to treat an acute injury, thereby providing therapy.
No
Explanation: The device is described as an occlusive wound dressing for treating penetrating chest wounds, and its function involves creating a seal and preventing air pressure increases, rather than identifying or analyzing a medical condition.
No
The device description clearly states it is an "adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve" or "adhesive dressing composed of a hydrogel based adhesive with a clear backing," indicating it is a physical, hardware-based medical device, 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 to be used as an occlusive wound dressing and temporary bandage for penetrating chest wounds. This is a therapeutic and protective function applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is an adhesive dressing with or without a valve, designed to be placed over a wound. This aligns with a wound care device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
- . To be used as an occlusive wound dressing.
- . To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
Product codes
NAD
Device Description
SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space .
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
emergency situations
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 Data: Performance testing demonstrated that the Chest Seal devices perform as well as, or better than, the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
0
MAR - 3 2011
Image /page/0/Picture/1 description: The image shows the logo for SAM Medical Products. The logo is in white text on a black background. The word "SAM" is in large, bold letters, and the words "MEDICAL PRODUCTS" are in smaller letters to the right of "SAM".
510(k) Summary The Seaberg Company, Inc. (dba SAM Medical Products, Inc.) SAM Chest Seal Product Family
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K102403
A. Submitter:
The Seaberg Company, Inc. (dba SAM Medical Products, Inc.) 27350 SW 95th Avenue, Suite 3038 Wilsonville, OR 97070
| Phone: | 503-639-5474 |
|---|---|
| Fax: | 503-639-5425 |
| Contact: | Jack N. McCutcheon |
| QARA Manager |
Date Prepared: August 9, 2010
B. Device Names:
Trade Name:
C.
-
- SAM® Chest Seal with Valve
-
- SAM® Chest Seal
| Common/usual Name: | Chest Seal |
|---|---|
| Classification Name: | Dressing Wound and Burn Occlusive |
| Predicate Device: | Asherman Chest Bandage, K942757 |
| Vaseline Petrolatum Gauze, K973512 |
D. Device Description:
SAM Chest Seal with Valve
The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space .
SAM Chest Seal 510(k)
1
Image /page/1/Picture/0 description: The image shows the logo for SAM Medical Products. The logo is in white text on a black background. The words "SAM" and "MEDICAL PRODUCTS" are stacked on top of each other, with a white line underneath the word "SAM". There is also some handwritten text in the upper right corner of the image, which appears to be "R102403 page 42".
SAM Chest Seal
The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.
E. Intended Use:
- . To be used as an occlusive wound dressing.
- . To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
F. Comparison with the Predicate Device:
There are no significant differences between the SAM® Chest Seal Product Family devices and the predicate devices that would adversely affect the use of the SAM® Chest Sed Product Family devices are substantially equivalent to the predicate devices in design, function, materials, and indications for use/intended use.
G. Non-clinical Data
Performance testing demonstrated that the Chest Seal devices perform as well as, or better than, the predicate device.
H. Clinical Data
Clinical data are not included in this submission.
I. Conclusions Drawn from Testing
Based on the data presented here, the SAM Medical Chest Seal devices are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
The Seaberg Company, Inc. % Mr. Jack N. McCutcheon 27350 SW 95" Avenue, Suite 3038 Wilsonville, Oregon 97070
Re: K102403
Trade/Device Name: SAM® Chest Seal with Valve SAM® Chest Seal Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: Class I Product Code: NAD Dated: February 10, 2011 Received: February 14, 2011
Dear Mr. McCutcheon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
MAR - 3 2011
3
Page 2 – Mr. Jack N. McCutcheon
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing on medical 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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm111800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Aling B. nh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K102403
Device Name: SAM Chest Seal with Valve SAM Chest Seal
Indications for Use:
- . To be used as an occlusive wound dressing.
- . To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daid Krone for MXM
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102403
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