(60 days)
Not Found
No
The device description and performance studies focus solely on the physical and barrier properties of a protective sheath for an OCT probe, with no mention of any software, algorithms, or data processing that would involve AI or ML.
No
This device is a protective sheath for an imaging probe, intended to prevent microbial transfer and fluid contamination. It does not directly provide therapy or treatment for a disease or condition.
No
The device described is a protective probe sheath, an accessory to an imaging system, designed to prevent the transfer of microorganisms. It does not perform diagnostic functions itself.
No
The device description clearly states it is a physical sheath constructed of rigid tubing, a flexible membrane window, and a plastic handle. It is a physical accessory for a medical imaging system, not a software-only device.
Based on the provided information, the Imalux OCT Probe Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to serve as a microbial barrier between the OCT probe and the patient's tissue. It is a protective accessory for the imaging system.
- Device Description: The description focuses on its physical construction and function as a barrier and protector for the probe.
- Performance Studies: The performance studies described relate to biocompatibility, mechanical strength, microbial barrier effectiveness, and sterilization. These are all characteristics of a barrier device, not a diagnostic test performed on a sample in vitro.
- No mention of analyzing biological samples: There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
The device is an accessory for an imaging system used in vivo (on the patient's tissue), and its primary function is to maintain sterility and protect the probe and patient. This aligns with the definition of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath for use as an accessory with the Imalux OCT Imaging System. The Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.
Product codes
NQQ, KKX
Device Description
The Imalux OCT (Optical Coherence Tomography) Probe Sheaths (Probe Sheaths) are sterile, single-use, protective sheaths for use with the Imalux OCT Imaging System. The sheaths are provided to fit the Imalux OCT Imaging System probe geometry and to help to prevent the transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the Probe.
The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
patient's tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare worker
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
The Probe Sheath was tested for biocompatibility per AAMI/ANSI/ISO 10993 for cytotoxicity, acute systemic toxicity, intracuteanous reactivity, sensitization, and ethylene oxide sterilization residuals. Testing was performed in accordance with ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices 21 CFR Part 58 (GLP). These tests demonstrated that the Probe Sheath device is non-toxic, non-irritating, non-sensitizing, and can be safely sterilized with ethylene oxide.
The Probe Sheath was verified for imaging, mechanical, and packaging performance. The Probe Sheath's materials and design have been shown to not impair the optical imaging performance of the Imalux OCT Imaging System. Mechanical verification of the Sheath, such as tensile strength, demonstrated that the Probe Sheath's distal end will withstand normal use.
Microbial barrier testing demonstrated that the Probe Sheath was capable of preventing the transmission of a challenge virus with a diameter of 25-27 nanometers (nm), smaller than most clinically significant viruses, to a detection limit of less than 5.5 x 10^7 milliliters (mL) of challenge virus suspension.
The Probe Sheath, individually packaged in its Tyvek/Mylar package, was successfully sterilized with 100% ethylene oxide. The sterilization was validated and verified to provide a sterility assurance level (SAL) of 10^-6. In addition, the Tyvek/Mylar package was verified for strength and integrity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
JUN 2 5 2004 510(k) SUMMARY
This summary is being submitted in accordance with 21 CFR 807.92.
Submitter's name, address, telephone number, initial importer, contact A. person
| Submitter's Name: | Imalux Corporation |
|---|---|
| Address: | 1771 East 30th Street |
| Address: | Cleveland, OH 44114 |
| Official Contact: | Stephanie A. S. Harrington |
| Title: | Vice President, Regulatory & Clinical |
| Affairs | |
| Telephone: | 216 502-0755 |
| Fax: | 216 622-0723 |
| E-mail: | harrington@imalux.com |
Device Name, Common Name B.
Common/Usual Name 1.
Probe Sheath
Device Name 2.
Imalux OCT Probe Sheath
Classification Name 3.
| Name | Classification
Regulation | Product Code | Class |
|-----------------------------------------------------------|------------------------------|--------------|-------|
| System, Imaging, Optical
Coherence Tomography
(OCT) | 892.1560 | NQQ | II |
C. Identification of the predicate or legally marketed device
| Device Name | 510(k) Number |
|---|---|
| CIVCO Medical Instruments Synthetic Polyisoprene | |
| Ultrasound Transducer Cover | K013721 |
| Vision-Sciences Slide-On™ EndoSheath® System for | |
| use with Flexible ENT Scopes | K990354 |
1
Device Description D.
Summary 1.
The Imalux OCT (Optical Coherence Tomography) Probe Sheaths (Probe Sheaths) are sterile, single-use, protective sheaths for use with the Imalux OCT Imaging System. The sheaths are provided to fit the Imalux OCT Imaging System probe geometry and to help to prevent the transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the Probe.
The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material.
Design 2.
The Probe Sheath is constructed of rigid tubing with a flexible end cap membrane window at one end and with a plastic handle at the other end. The probe is inserted into the tubing at the handle and fed through the tubing until the probe's distal tip is flush with the Probe Sheath's membrane window. The handle includes a lock nut to secure the probe in place. The Probe Sheath is provided in various dimensional configurations necessary to accommodate the probe as well as to assist the user in probe positioning.
Probe Sheaths are provided as sterile, single-use sheaths, individually packaged in Tyvek/Mylar pouches.
Materials 3.
The Probe Sheath is constructed of commonly used medical device materials and has been evaluated for biocompatibility. This evaluation has demonstrated that the Probe Sheath is safe for its intended use.
The intended use and indications for use place the Probe Sheath in the device body contact categories as follows:
- a. surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (