(191 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a protective restraint, with no mention of AI or ML technologies.
No
The device is described as limiting patient movements for "treatment, examination, or protection of the patient or others," but it does not directly treat a medical condition.
No
The device is a "Protective Restraint" used to limit patient movement for treatment or protection, which is a therapeutic or protective function, not a diagnostic one.
No
The device description explicitly states it is comprised of physical materials (hook and loop material, nylon fabric, polyester foam core, nylon tricot backing), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Centurion® Protective Restraint Function: The description clearly states that this device is a physical restraint used to limit patient movement for medical purposes. It does not involve the analysis of biological specimens.
The information provided describes a physical medical device, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
Contraindications:
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
Product codes (comma separated list FDA assigned to the subject device)
FMQ,FMO
Device Description
The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
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
neonatal/newborn patients
Intended User / Care Setting
by or on the order of a physician in a hospital or clinic setting.
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)
Comparative bench performance testing was performed to evaluate the physical integrity and performance of the device and its predicate. The results demonstrate that the device satisfies all performance, physical, and functional requirements and the device is as safe, as effective, and performs as well as the predicate device. No new issues of safety or efficacy were 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.
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
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Koto441
Image /page/0/Picture/1 description: The image shows a logo for Tri-State Hospital Supply Corporation. The logo features a graphic of a person in the upper left corner. Below the company name is the text "MANUFACTURERS OF" and then the word "CENTURION" in large, bold letters. Below that is the text "HEALTHCARE PRODUCTS".
P.O. Box 170 · Howell, MI 48844 (517) 546-5400 • (800) 248-4058 • Fax (517) 546-9388 www.tshsc.com • e-mail: info@tshsc.com
| 510(k) Summary | AUG 2 8 2008 |
|---|---|
| Manufacturer: | Tri-State Hospital Supply Corporation |
| 301 Catrell Drive | |
| Howell, MI 48843 | |
| Contact: | Mr. Matthew K. Price |
| Director of Quality Assurance & Regulatory Affairs | |
| Tri-State Hospital Supply Corporation | |
| 301 Catrell Drive | |
| Howell, MI 48843 | |
| Phone: (517) 546-1135 | |
| Facsimile: (517) 546-3356 | |
| Date Summary Prepared: | February 15, 2008 |
| Proprietary Name: | Centurion® Protective Restraint |
| Common Name of Device: | Protective Restraint |
| Classification Name: | Restraint, Protective |
| Device Classification: | Class I |
| Regulation: | 880.6760 |
| Product Code: | FMQ |
| Panel: | General Hospital |
Predicate SE Device(s):
This product is similar in design, composition, function, and method of use to the Posey Company Pediatric Limb Holder (K963439).
Description:
The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
Intended Use:
The Centurion® protective restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
Summary of Technological Characteristics between Subject and Predicate Device:
The predicate device (K963439) provides the same functions, characteristics described herein for the device. Although there are some dimensional differences between the predicate device and the Centurion® Protective Restraint, the difference is minor and raises no new questions of safety or effectiveness.
1
Summary of Testing:
Comparative bench performance testing was performed to evaluate the physical integrity and performance of the device and its predicate. The results demonstrate that the device satisfies all performance, physical, and functional requirements and the device is as safe, as effective, and performs as well as the predicate device. No new issues of safety or efficacy were found.
. . .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP 9-2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew K. Price Director of Quality Assurance & Regulatory Affairs Tri-State Hospital Supply Corporation 301 Catrell Drive Howell, Michigan 48843
Re: K080448
Trade/Device Name: Centurion® Protective Restraint Regulation Number: 21 CFR 880.6760 Regulation Name: Protective Restraint Regulatory Class: I Product Code: FMO Dated: August 20, 2008 Received: August 21, 2008
Dear Mr. Price:
This letter corrects our substantially equivalent letter of August 28, 2008.
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 (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 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. Price
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
JHommels-Lendm-D foell
Chu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K080448
Device Name: Centurion® Protective Restraint
Indications for Use:
The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
Contraindications:
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080448
Page 1 of
Centurion® Protective Restraint 510(k) Submission
4-2 (REVISED)
Indications for Use