(75 days)
Not Found
No
The device is a simple protective cover for a biopsy device holster and does not involve any computational or analytical functions.
No
The device is a protective cover for a mechanical breast biopsy device, designed to prevent contamination and allow for reprocessing of the holster. It does not directly provide a therapeutic effect to a patient.
No
Explanation: The device is described as a "protective cover for a mechanical breast biopsy device," designed to prevent contamination and allow reprocessing of the holster. It does not perform any diagnostic function itself.
No
The device is a physical cover made of polyurethane film and thermoplastic elastomer bands, designed to protect a mechanical breast biopsy device. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a protective cover for a mechanical breast biopsy device holster to prevent contamination and allow for reprocessing. This is a physical barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the cover (material, design, packaging) and its function as a barrier. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of:
- Analyzing biological samples (blood, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic results or interpretations
- Any form of in vitro testing
The device's function is purely to protect and facilitate the reprocessing of another medical device used in a diagnostic procedure (breast biopsy), but it does not perform the diagnostic test itself. It's an accessory to a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The CIV-Flex™ Holster Cover is a protective cover for a mechanical breast biopsy device reusable holster / cable assembly that helps prevent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for reprocessing of the holster between patient uses; covers are single use, disposable.
Product codes
78 KNW
Device Description
The CIV-Flex™ Holster Cover device provides a thin, conformal protective covering for the disposable probe / reusable holster and cable assembly components of the Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device. The cover is manufactured as a one-piece sleeve design that is open on both ends with a tapered fit to the holster / probe geometry. The cover material is transparent for visualization of the holster control buttons during use.
Cover material is polyurethane film. Material system is free of any latex natural rubber. The polyurethane material was introduced into CIVCO products as CIV-Flex™ Ultrasound Transducer Covers in 1987. This polyurethane material has been used in CIVCO ultrasound transducer cover applications for over ten (10) years. Thus, this material can fall under a "GRAS" (Generally Recognized As Safe) classification.
Covers are packaged sterile in a pouch for single patient / procedure, disposable use. Cover is supplied with latex free Kraton® thermoplastic elastomer bands for use in securing the cover to the holster and cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical testing for CIV-Flex™ Holster Covers has shown that the material is adequate for the intended use:
a) during application and removal of cover from holster, b) during use as intended.
Strength and elastic characteristics are the same as that of the ultrasound cover allowing use without tearing or pinholing. same cover thickness of .002".
Experience and testing has shown that polyurethane covers:
polyurethane has sufficient strength and elasticity for the intended use. Nominal cover thickness is .002". Provides an effective barrier to the prevention of microbial migration as demonstrated using protocol adapted from that used to evaluate the barrier properties / resistance of surgical gloves and endoscope sheaths to penetration by bloodborne pathogens using viral penetration as a test method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
(As required by 21 CFR 807.92)
CIV-Flex™ Holster Cover
A. General Information
| Submitter's Name: | CIVCO Medical Instruments Company, Inc. |
|---|---|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone (319) 656-4447 fax: (877) 248-6304 |
| Contact Person: | J. William Jones, Manager - Regulatory Affairs |
Date Prepared:
16 August 2000
1937223 Establishment Registration Number: CIVCO Medical Instruments is registered as a medical device manufacturer.
Device Trade: Device Common: Device Classification Name: CIV-Flex™ Holster Cover Biopsy Device Accessory Biopsy Instrument Cover
Classification: Classification Panel: Classification Procode: Class II under 21 CFR 876.1075 Gastroenterology 78 KNW
Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
B. Device Description
The CIV-Flex™ Holster Cover device provides a thin, conformal protective covering for the disposable probe / reusable holster and cable assembly components of the Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device. The cover is manufactured as a one-piece sleeve design that is open on both ends with a tapered fit to the holster / probe geometry. The cover material is transparent for visualization of the holster control buttons during use.
Cover material is polyurethane film. Material system is free of any latex natural rubber. The polyurethane material was introduced into CIVCO products as CIV-Flex™ Ultrasound Transducer Covers in 1987. This polyurethane material has been used in CIVCO ultrasound transducer cover applications for over ten (10) years. Thus, this material can fall under a "GRAS" (Generally Recognized As Safe) classification.
Covers are packaged sterile in a pouch for single patient / procedure, disposable use. Cover is supplied with latex free Kraton® thermoplastic elastomer bands for use in securing the cover to the holster and cable.
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C. Intended Use / Indications for Use
The CIV-Flex™ Holster Cover is a protective cover for a mechanical breast biopsy The CIV-Plex -- Thoister Gover 16 a provent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for hulds, ultrasound get, etc.] of the holor oonlier batterie, a are single use, disposable.
D. Predicate Device
The CIV-Flex™ Holster Cover device is identified as substantially equivalent to CIVCO Medical's currently, legally marketed Poly [CIV-Flex™] Ultrasound Transducer Covers:
Predicate Device(s) Poly [CIV-Flex™] Ultrasound Transducer Cover
510(k) Reference K970513
Manufacturer CIVCO Medical
E. Substantial Equivalence Summary
The CIV-Flex™ Holster Cover is substantially equivalent in safety and effectiveness to the CIVCO Poly [CIV-Flex™] Ultrasound Transducer Cover. The comparison table on the following pages demonstrates this substantial equivalence.
F. Conclusions
Ethicon Endo-Surgery User's Manual for the Mammotome® Hand-Held System indicates the holster / cable device is a non-sterile instrument and cannot be reprocessed between the norsel 7 cable do not is a non exercion methods. Reducing the contamination level pations allows for reprocessing of the holster device by the instructed cleaning by covening allowe for reploseaaked with enzymatic detergent / removing residual methou of wiping with a clear-ended sleeve type cover is not intended to be a sterile downlor. The holster is required to be cleaned after every use regardless of whether a sterile cover was used or not. Testing of the cover system has demonstrated satisfactory performance for contamination reduction.
This premarket submission for the CIV-Flex™ Holster Cover has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Devices and Radiological Health.
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CIV-Flex™ Holster Cover
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Comparison of Device to Substantially Equivalent, Legally Marketed Device
| Parameter | CIV-Flex™ Holster Cover | Predicate Device
CIVCO Poly Ultrasound
Transducer Cover (K970513) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | Same, except subject device is a
mechanical breast biopsy reusable
holster / cable assembly instead of an
ultrasound transducer. | A protective cover that helps prevents
contamination [blood, body fluids,
ultrasound gel, etc.] and thus allowing
for reprocessing of the device between
patient uses. Covers are single use,
disposable. |
| Design | Same. | One-piece, geometry conforming cover. |
| Material | Same. | polyurethane, thermoplastic. CIVCO trade name CIV-Flex™. effectively used for over 10 years. |
| Manufacturing | Same. | extruded / blown thin film sheet. cut / heat seal fabricated & packaged in a Class 10,000 cleanroom per Federal Std 209e. sterile packaging material system per ANSI / AAMI / ISO 11607. sterilized by ethylene oxide gas. |
| Quality Systems | Same. | FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same. | sterilization by 100% EtO method. validated ANSI / AAMI / ISO 11135. SAL 10-6. |
| Device Body
Contact Category | Same. | surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (