LogoFDA 510(k) Search
K Number
K121284
Device Name
CHABNER XRT GARMENTS
Manufacturer
BFFL CO. INC
Date Cleared
2013-06-14

(410 days)

Product Code
IYE
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT™ Garments are not intended for pediatric use.
Device Description
The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are < 1 mm in thickness. Clear thermoplastic polyurethane (TPU) windows are incorporated into the device to enable clinicians to view index tattoos, the midline, bony landmarks, and other treatment parameters, as created by the light field that is projected by the treatment or diagnostic machine onto the patient's body. The compressive nature of the materials used in the device's construction, along with various adjustment features incorporated into the device, assist the clinician in positioning the body and to reproduce the desired body geometry, treatment position, and patient-to-machine alignment prior to each radiological procedure. Radiation passes through the TPU material without affecting therapy or diagnosis. Because the device is worn as a garment, they offer the added benefit of protecting the patient's dignity during such procedures that, in turn, increases the patient's overall comfort during the process.
More Information

K111340, K982624

Not Found

No
The device description focuses on the physical properties and function of a garment for patient support and positioning during radiological procedures. 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" and "Description of the training set..." sections are explicitly marked as "Not Found".

No.
The device is intended for patient support and positioning during diagnostic and therapeutic radiological procedures, not for treating any specific medical condition or disease.

No

The device is a non-sterile garment intended to support and position patients during diagnostic radiological procedures. It aids in patient positioning and dignity, but it does not perform any diagnostic function itself.

No

The device description clearly states it is a "non-sterile garment worn by patients" and describes physical components like "thermoplastic polyurethane (TPU) windows" and "adjustment features," indicating it is a physical medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Function: The Chabner XRT™ Garments are external garments worn by the patient to aid in positioning and support during imaging and radiotherapy procedures. They do not analyze any biological specimens.
  • Intended Use: The intended use clearly states the purpose is for support and positioning during radiological procedures, not for analyzing samples.
  • Device Description: The description focuses on the physical characteristics of the garment and its function in patient positioning and comfort.

Therefore, the Chabner XRT™ Garments fall under the category of medical devices used for patient support and positioning during imaging and treatment, not as an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures.
The Chabner XRT™ Garments are not intended for pediatric use.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures.
There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

K121284
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510(k) Summary

"510(k) Summary" As required by section 807.92(c) For Chabner XRT™ Garments

June 3, 2013

  1. 'Company Name and Address

a. Sponsor/Manufacturer

Bffl Co. Inc. 20 Kensington Road Scarsdale, NY 10583

b. Consultant/Contact

Evan P. Phelps OFW Law 600 New Hampshire Ave, Ste. 500 Washington D.C. 20037 ephelps@ofwlaw.com Tel: (202) 789-1212 Fax: (202) 234-3550

  1. Establishment Registration Number:

Not yet assigned

    1. Device Name:
    • a. Trade Name:

Chabner XRT™ Garments

Therapy System

Patient Support and Positioning Garments

Accessory to Medical Charged-Particle Radiation

Common/Usual Name: b.

Classification Name: C.

4. Device Classification:

a. 21 C.F.R. § 892.5050 (Class 11)

b. Product Code: IYE

c. Classification Panel: Radiology JUN 1 4 2013

1

5. Legally Marketed Predicate Devices:

  • a. MR Patient Positioning Devices
    • i. 510(k) Owner: Med-Tech, Inc. (d.b.a. CIVCO Medical Solutions)
    • ii. 510(k) Number: K111340
    • iii. 21 C.F.R. § 892.5050 (Class II)
    • iv. Product Code: IYE
  • b. Moldcare Head & Neck Cushion
    • i. 510(k) Owner: Med-Tec., Inc.
    • ii. 510(k) Number: K982624
    • iii. 21 C.F.R. § 892.5050 (Class II)
    • iy. Product Code: IYE

6. Device Description

The device is a non-sterile garment worn by patients as an aid in the support and positioning of patients during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures.

There are three versions of the garment: 1) brassiere; 2) athletic style shorts; and 3} girdle. All versions of the device are devoid of metal and can be worn for use with all treatment or diagnostic machines without causing a bolus (i.e., the materials do not mimic the properties of tissue during a radiological procedure) or attenuation effect. All materials used in the device's construction are