(179 days)
Not Found
No
The device is a physical drape for ultrasound probes and does not involve any software or data processing.
No
The device, an ultrasound probe drape, is intended to maintain a sterile field, protect from contaminants, and protect the ultrasound probe. It does not exert any therapeutic action on the patient.
No
The device is an ultrasound probe drape, which is an accessory used during an ultrasound imaging procedure. It is not an ultrasound imaging device itself and does not perform any diagnostic functions. Its purpose is to maintain a sterile field, protect from contamination, and protect the ultrasound probe.
No
The device description clearly outlines physical components such as polyurethane film, polyethylene film, foil packets of gel, and elastomer bands, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an ultrasound probe drape used during a medical ultrasound imaging procedure. Its purpose is to maintain a sterile field, protect from contaminants, and protect the probe. It does not mention analyzing samples from the human body to provide diagnostic information.
- Device Description: The description details a physical covering for an ultrasound probe, made of materials like polyurethane and polyethylene. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description and intended use do not align with the typical characteristics of an IVD, which involve testing samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
The device is a medical device used in conjunction with an imaging procedure, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.
Product codes
IYO
Device Description
Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact.
Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure.
Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.
When the Ultrasound Probe Drape is used as intended, ultrasound imaging is not impaired. Adequate coupling between the Drape and the probe normally is accomplished by applying an appropriate amount of ultrasound coupling gel to the ultrasound probe before application of the Drape. Once the Drape is fully applied, any excess Drape material covering the probe cable is gathered by means of elastic bands for neatness and convenience and to hold the Drane in place. The removal process for the Ultrasound Probe Drape is accomplished by removing the elastic bands, pulling off the Drape, disposing of those materials, and appropriately cleaning any remaining gel from the ultrasound probe, in a reverse method from the application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner
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)
Evidence of compliance with ANSI/AAMI PB70, a Recognized Consensus Standard for barrier performance of Product Code KKX Surgical Drapes, and of independent-certifiedlaboratory determination of biocompatibility per Recognized Consensus Standard ISO 10993, is provided to demonstrate further equivalency to the predicate devices.
Representative post-sterilization samples from CFI's device group were tested per Cytotoxicity Evaluation (ISO 10993-5:1999) per Fluid Extract/L929 Mouse Fibroblast; Primary Skin Irritation (ANSI/AAMI/ISO 10993-10:2002); Dermal Sensitization Maximization (ISO 10993-10:2002 (0.9% NaCl Extract); and Dermal Sensitization Maximization (ISO 10993-10:2002 (Cottonseed Oil Extract), for safe use under conditions of limited contact (
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Sep 18 2009
510(k) Summary
510(k) Owner
Address Voice Number Fax Number Name of Contact Person
Contour Fabricators, Inc. ("CFI") 14241 Fenton Road, Fenton, MI 48430 (810) 750-5300 . (810) 750-5310
John W. Schaefer, Regulatory Manager
Establishment Registration Number 1825560 Contour Fabricators, Inc. is FDA registered as a medical device manufacturer,
Device Trade or Proprietary Name Device Common or Usual Name Device Classification Name Classification Classification Panel Classification Product Code
CFI Ultrasound Probe Drape Ultrasound Probe Drape System, Imaging, Pulsed Echo, Ultrasonic Class II under 21 CFR 892.1560 90 Radiology IYO
Description of Devices Submitted for Premarket Notification:
Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material.
Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact.
Phone 810.750.5300 Fax 810.750.5310
CFI Medical Solutions 14241 Fenton Road Fenton, MI 48430
sales(a)cfimedical.com
1
Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure.
Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.
When the Ultrasound Probe Drape is used as intended, ultrasound imaging is not impaired. Adequate coupling between the Drape and the probe normally is accomplished by applying an appropriate amount of ultrasound coupling gel to the ultrasound probe before application of the Drape. Once the Drape is fully applied, any excess Drape material covering the probe cable is gathered by means of elastic bands for neatness and convenience and to hold the Drane in place. The removal process for the Ultrasound Probe Drape is accomplished by removing the elastic bands, pulling off the Drape, disposing of those materials, and appropriately cleaning any remaining gel from the ultrasound probe, in a reverse method from the application.
Evidence of compliance with ANSI/AAMI PB70, a Recognized Consensus Standard for barrier performance of Product Code KKX Surgical Drapes, and of independent-certifiedlaboratory determination of biocompatibility per Recognized Consensus Standard ISO 10993, is provided to demonstrate further equivalency to the predicate devices.
Description of Predicate Devices
The bundled Contour Fabricators, Inc. Ultrasound Probe Drape designs are based on, and are equivalent in dimensions, technology, materials, and intended use to selected ultrasound probe drapes that are manufactured by Civco Medical Instruments Company, Inc. and legally marketed per premarket notification K970513. A listing of specific equivalencies is provided in the Device Description section. Contour Fabricators, Inc. does not make equivalent models to all
PHONE (810) 750-5300 Fax (810) 750-5310
2
models made by Civco, including Civco models made for certain applications that involve contact with broken skin, mucous membranes, and external blood paths. Therefore the scope of this premarket notification is less broad than that of the Civco 510(k) cited as the Predicate.
Intended Use / Indications for Use:
These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.
Comparison of Submitted Devices to Substantially Equivalent, Legally Marketed Devices
| Intended Use: | Both device groups provide a thin, conformal protective cover / drape system
for ultrasound transducer / probe usage in body-surface patient environments.
Both help to provide for maintenance of a sterile field (sterile covers only), to
help protect the patient and healthcare worker from transfer of contaminants
and biological risk agents (sterile and non-sterile covers), and to protect the
ultrasound probe from contamination that could adversely affect its
functionality or create downtime and require cleaning procedures (sterile and
non-sterile covers). Both are single patient/procedure, disposable devices,
furnished sterile or non-sterile, in most cases as an element of a kit-product
that also includes a foil packet of ultrasound coupling gel, which always is
pre-sterilized. |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | one end and closed on the other end, with various dimensional configurations
as necessary to accommodate differences in ultrasound transducer / probe
geometries. Both are designed to be applied over the transducer / probe with
the open end of the ultrasound probe drape extending along the connecting
cable, and the closed end of the drape arranged against the working face of the |
| | transducer / probe. |
| Materials: | Both device groups are constructed primarily of polyurethane film, a
customary ultrasound probe drape material. Polyurethane film has been
effectively and safely used in ultrasound probe drapes for approximately
twenty years. Some designs of both device groups additionally utilize
polyethylene film, a customary material in medical-device drapes and covers,
other medical disposables, pharmaceutical packaging and food containers and
packaging. Polyethylene film has been effectively and safely used in medical-
device, pharmaceutical and food applications for approximately thirty-five
years. |
| | Most product versions include a pre-sterilized foil packet of ultrasound
coupling gel and two sterile synthetic elastomer (non-latex) bands that are
customarily used to control extra "bulk" of drape material in the vicinity of
the application procedure.
These devices normally are colorless-transparent; which is the natural
(unpigmented) color of the polyurethane film and (if present) the polyethylene
film. Ancillary components such as elastic bands (which normally do not have
patient contact) may have other colors. |
| Manufacturing: | CFI's device group is made using validated heat-seal fabrication processes,
with specification-compliance-controlling operations conducted in certified,
validated ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging
(when applicable) is validated per ISO 11607. EtO sterilization (when
applicable) is conducted by an appropriately certified, audited sterilization |
| | subcontractor utilizing processes validated per ISO 11135. All operations are
subject to the CFI quality management system. |
| | The predicate device group is made using "impulse heat-seal cover
fabrication, packaging (in class 10,000 cleanroom), and EtO sterilization
(when applicable)". |
| Safety: | Both device groups have been evaluated for potential adverse effects to the
healthcare worker and patient by means of biological testing by an
appropriately certified test laboratory. Representative post-sterilization
samples from CFI's device group were tested per Cytotoxicity Evaluation
(ISO 10993-5:1999) per Fluid Extract/L929 Mouse Fibroblast; Primary Skin
Irritation (ANSI/AAMI/ISO 10993-10:2002); Dermal Sensitization
Maximization (ISO 10993-10:2002 (0.9% NaCl Extract); and Dermal
Sensitization Maximization (ISO 10993-10:2002 (Cottonseed Oil Extract), for
safe use under conditions of limited contact (