(157 days)
Zoex Antishock Trousers [870.5800]
Not Found
No
The device description details a purely mechanical device with no mention of software, algorithms, or data processing.
Yes
The device is used to prevent a decrease in central blood volume and to control hemorrhaging, which are therapeutic interventions. Its predicate device is an "Antishock Trousers."
No
The device's purpose is to prevent a decrease in central blood volume and control hemorrhaging, which are therapeutic actions, not diagnostic.
No
The device description clearly details physical components such as a composite board, straps, hinges, a metal ratchet, a cam-lock, and an eyebolt, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- BODY FORCE Function: The BODY FORCE is a physical device applied directly to the patient's body to prevent a decrease in central blood volume and as a tourniquet. It does not involve the analysis of any biological specimens.
The description clearly indicates a device used externally on the patient for mechanical support and pressure, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The BODY FORCE is a medical device used on patients who have experienced an abdominal/ pelvic crush injury. The purpose is to prevent a decrease in the central blood volume during transportation to a trauma center.
Indications for use are: (Tourniquet)
- Uncontrollable hemorrhaging in the leg(s)
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The BODY FORCE is a composite board, measuring eighteen inches (18") long and eight inches (8") wide and seven-eighths inches (7/8") thick with a loose strap on one side that is two inches (2") wide and seventy inches (70") long. On the other side is a strap that is also two inches (2") wide but only six inches (6") long with a metal ratchet sewn into it. The straps are sewn into a three sixteenth inch (3/16") X fourinch (4") wide stainless steel hinges, with a non-removable pin. The hinges will be held down to the plate by a cam-lock that passes through the board in slots that enable it to be adjusted to several different sizes. There is also a long gated eyebolt that locks into the center of the board that is designed to be used as a bilateral tourniquet for the lower extremities.
The intended use of this device is for all serious crushing injuries of the abdomen and pelvis area. With the signs and symptoms of shock present, and an almost certain death if the object is removed prior to the application of this device. The BODY FORCE can double as a tourniquet to the lower extremities with the eyebolt placed into the center of the board. The long strap is fed over the leg and through the evebolt and over the other leg into the ratchet and tightened to form a tourniquet. If needed for only one leg, omit the eyebolt and use as if on the abdomen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal/ pelvic, leg(s)
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): 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.
Zoex Antishock Trousers [870.5800]
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
JUN 2 8 2002
EAST COAST COMPOSITE TECNOLOGIES, LLC 1940 OLD DUNBAR RAOD WEST COLUMBIA S.C. 29172 PHONE (803) 233-0043 FAX (803) 822-8582
PREMARKET NOTIFICATION | 510(K) |
Submitted by: Randy Sisk
Completed:
January 16, 2002
Device Trade Name: BODY FORCE
COMMON NAME BODY TOURNIQUET
CLASSIFICATION NAME COMPRESSIBLE LIMB SLEEVE
1
Summary
This will show that the BODY FORCE is equilivant to the Zoex Antishock Trousers [870.5800], in several ways. It will also show a greater life saving benefit.
The BODY FORCE is a composite board, measuring eighteen inches (18") long and eight inches (8") wide and seven-eighths inches (7/8") thick with a loose strap on one side that is two inches (2") wide and seventy inches (70") long. On the other side is a strap that is also two inches (2") wide but only six inches (6") long with a metal ratchet sewn into it. The straps are sewn into a three sixteenth inch (3/16") X fourinch (4") wide stainless steel hinges, with a non-removable pin. The hinges will be held down to the plate by a cam-lock that passes through the board in slots that enable it to be adjusted to several different sizes. There is also a long gated eyebolt that locks into the center of the board that is designed to be used as a bilateral tourniquet for the lower extremities.
The intended use of this device is for all serious crushing injuries of the abdomen and pelvis area. With the signs and symptoms of shock present, and an almost certain death if the object is removed prior to the application of this device. The BODY FORCE can double as a tourniquet to the lower extremities with the eyebolt placed into the center of the board. The long strap is fed over the leg and through the evebolt and over the other leg into the ratchet and tightened to form a tourniquet. If needed for only one leg, omit the eyebolt and use as if on the abdomen.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Composite Solutions, Inc. c/o Mr. Randy Sisk President 1940 Old Dunbar Road West Columbia, SC 29172
Re: K020211
Trade Name: Body Force. Model BT-6000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: May 15, 2002 Received: May 17, 2002
Dear Ms. Sisk:
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.
3
Page 2 - Mr. Randy Sisk
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 594-4646. 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,
- Bonna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page · 1_of _1
510(k) Number (if known): K020211
Device Name: BODY FORCE
Indications for Use:
STATEMENT OF INDICATIONS FOR USE
Indications for use
The BODY FORCE is a medical device used on patients who have experienced an abdominal/ pelvic crush injury. The purpose is to prevent a decrease in the central blood volume during transportation to a trauma center.
Indications for use are: (Tourniquet)
- Uncontrollable hemorrhaging in the leg(s)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices
510(k) Number K020211
510(k) Number