(191 days)
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.
The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
The provided text describes a 510(k) premarket notification for the Centurion® Protective Restraint. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety or effectiveness through extensive clinical trials. Therefore, the study described is a comparative bench performance test.
Here’s an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Integrity | Not explicitly detailed, but implied: ability to withstand forces of restraint, maintain structural integrity. | The device satisfies all performance, physical, and functional requirements. |
| Performance | Not explicitly detailed, but implied: ability to effectively limit patient movement as intended. | The device satisfies all performance, physical, and functional requirements. |
| Functional Requirements | Not explicitly detailed, but implied: proper operation of hook and loop material, appropriate design for neonatal/newborn use, secure fastening. | The device satisfies all performance, physical, and functional requirements. |
| Safety | Not explicitly detailed, but implied: no new safety concerns compared to the predicate device. | No new issues of safety or efficacy were found. The device is as safe as the predicate device. |
| Effectiveness | Not explicitly detailed, but implied: performing its intended use to limit patient movement, comparable to the predicate device. | No new issues of safety or efficacy were found. The device is as effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text only mentions "Comparative bench performance testing was performed."
- Data Provenance: The study was a "bench performance testing," implying it was conducted in a laboratory setting, likely by the manufacturer (Tri-State Hospital Supply Corporation). There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as this was a bench performance test, not a clinical study involving human judgment on clinical outcomes. Ground truth for a bench test would be based on engineering specifications and direct measurements against those specifications.
4. Adjudication Method for the Test Set
- This is not applicable/not provided as no human expert adjudication of clinical performance was involved in this bench test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- No, an MRMC comparative effectiveness study was not done. The submission describes a 510(k) for a Class I device, which relies on demonstrating substantial equivalence through bench testing, not clinical studies like MRMC.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- This question is not applicable as the device is a physical protective restraint, not an AI algorithm or software.
7. The Type of Ground Truth Used
- The ground truth for this bench testing would have been based on pre-defined engineering specifications, material properties, and functional requirements for protective restraints, derived from regulatory standards, internal product design specifications, and the characteristics of the predicate device. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This section describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this device does not utilize AI/ML and therefore does not have a "training set" or ground truth established for one.
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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 Corporation301 Catrell DriveHowell, MI 48843 |
| Contact: | Mr. Matthew K. PriceDirector of Quality Assurance & Regulatory AffairsTri-State Hospital Supply Corporation301 Catrell DriveHowell, MI 48843Phone: (517) 546-1135Facsimile: (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.
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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.
. . .
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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.
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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
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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
§ 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.