(410 days)
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.
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.
The provided document, K121284, is a 510(k) summary for the Chabner XRT™ Garments, a patient support and positioning device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested details about acceptance criteria, efficacy studies, and ground truth establishment are not explicitly present in this type of regulatory submission, which is for demonstrating substantial equivalence rather than novel efficacy.
Here's an attempt to extract and describe the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria or detailed performance results from a study directly comparing the Chabner XRT™ Garments against such criteria. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on shared fundamental characteristics.
| Acceptance Criterion (Implied by Predicate Equivalence) | Reported Device Performance (Chabner XRT™ Garments) |
|---|---|
| Intended Use: Aid in patient support and positioning during various radiological procedures. | Reported: "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." (Matches predicate) |
| Radiotranslucency: Allows radiation to pass through without affecting therapy or diagnosis. | Reported: "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...All materials used in the device's construction are < 1 mm in thickness." (Implies radiotranslucency, matches predicate) |
| Conforms to patient's body shape: Ability to fit and support the patient's body. | Reported: "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..." (Implies conformance, matches predicate) |
| Device Body Contact Category: Surface devices, intact skin; limited contact duration (<24 hours). | Reported: "Surface devices, intact skin; limited contact duration (<24 hours)." (Matches predicate) |
| Safety and Efficacy: No significant differences in safety and efficacy compared to predicates. | Reported: "There are no significant differences between the Chabner XRT™ Garments and the predicate devices...This difference does not affect the device's safety and efficacy." (Conclusion of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a study involving human subjects or data where performance metrics were measured. This is a 510(k) submission focused on demonstrating substantial equivalence through comparison to existing devices, not a clinical trial or performance study with a test set in the traditional sense. Therefore, details about sample size, country of origin, or retrospective/prospective nature are not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no described "test set" or performance study, there is no information on experts establishing ground truth.
4. Adjudication Method
Not applicable, as no test set or expert adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a MRMC comparative effectiveness study. The submission focuses on the physical and functional characteristics of the garment compared to predicate devices, not on the impact of the device on human reader performance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is a physical medical device (garment), not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable here. Its performance is inherent in its physical properties and how it aids patient positioning.
7. Type of Ground Truth Used
Given the nature of the submission (substantial equivalence for a physical garment), the "ground truth" is established by showing that the device shares fundamental technological characteristics and intended use with other legally marketed devices. It's not based on expert consensus, pathology, or outcomes data in the context of a performance study validating specific diagnostic or therapeutic efficacy. Instead, it relies on regulatory precedent and comparison of device features.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. There is no algorithm or model that requires training data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
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K121284
Page 1 of 4
510(k) Summary
"510(k) Summary" As required by section 807.92(c) For Chabner XRT™ Garments
June 3, 2013
- '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
- Establishment Registration Number:
Not yet assigned
-
- 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
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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 < 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.
-
- 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.
- Intended Use
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The Chabner XRT™ Garments are not intended for pediatric ,use.
8. Technological Characteristics and Substantial Equivalence Evaluation
The Chabner XRT™ Garments are substantially equivalent in terms of intended use, operating principles, and operational specifications to CIVCO's MR Patient Positioning Devices (K111340) and Med-Tec. Inc.'s Moldcare Head and Neck Cushion (K982624) which are both legally marketable patient support and positioning aids classified by the agency as accessories to medical charged-particle radiation therapy systems. Like the CIVCO MR Patient Positioning Devices and Med-Tec. Inc. Moldcare Head and Neck Cushion, the Chabner XRT™ Garments are intended to be used as an aid in the support and positioning of patients during MR, radiological, and other procedures, are radiotranslucent, conform to the individual patient's body shape, and contact the body for less than a 24 hour period of time.
| Feature | Chabner XRT™Garments | MR PatientPositioning Devices | Moldcare Head &Neck Cushion |
|---|---|---|---|
| K111340 | K982624 | ||
| CIVCO | Med-Tec, Inc. | ||
| Indications for Use | Chabner XRT™Garments areintended to be usedas an aid in thesupport of thepatient during X-ray,computedtomography,magnetic resonanceimaging,radiotherapy, andother diagnosticradiologicalprocedures.The Chabner XRT™Garments are notintended forpediatric use. | CIVCO patientPositioning devicesare used to aid in thesupport andpositioning of patientsduring MR,radiological, and otherprocedures. | The intended use ofthis device is toprovide an additionalaid to the fast andaccurate repeatpositioning of thepatient for radiation orother treatment. Thedevice forms to theback of the patient'shead and eliminatesthe usual range ofmovement of ordinaryhead cups. |
| Radiotranslucent | Yes | Yes | Yes |
| Conforms to patient'sbody shape | Yes | Yes | Yes |
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K121284
Page 4 of 4
| Device Body ContactCategory (ISO 10993-1) | Surface devices,intact skin; limitedcontact duration(<24 hours). | Surface devices, intactskin; limited contactduration (<24 hours). | Surface devices, intactskin; limited contactduration (<24 hours). |
|---|---|---|---|
| ----------------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
There are no significant differences between the Chabner XRT™ Garments and the predicate devices. However, they do differ from the predicate devices in that they are produced as wearable compression garments that have the added benefit of protecting patient dignity; whereas, the predicate devices are not worn on the body. This difference does not affect the device's safety and efficacy.
-
- Substantial Equivalence Conclusion
The Chabner XRT™ Garments are substantially equivalent to the CIVCO MR Patient Positioning Devices and Med-Tec. Inc. Moldcare Head and Neck Cushion with respect to intended use, safety, and effectiveness.
- Substantial Equivalence Conclusion
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 14, 2013
BFFL Co., Inc. % Mr. Evan P. Phelps Counsel OFW Law 600 New Hampshire Avenue, NW, Suite 500 WASHINGTON DC 20037
Re: K121284
Trade/Device Name: Chabner XRT Garments Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 10, 2013 Received: May 15, 2013
Dear Mr. Phelps:
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 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 practice requirements as set
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Page 2 - Mr. Phelps
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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Michael D. O'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure-
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Indications for Use
510(k) Number (if known): K121284
Device Name: Chabner XRT Garments
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 XRTTM Garments are not intended for pediatric use.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Porti
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K121284
Page 1 of 1
§ 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.