(75 days)
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.
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. 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.
The information provided describes a 510(k) premarket notification for the CIV-Flex™ Holster Cover, focusing on demonstrating substantial equivalence to a predicate device, the CIVCO Poly [CIV-Flex™] Ultrasound Transducer Cover (K970513). As this is a submission for a protective cover, the "performance" and "acceptance criteria" are related to its physical properties, biocompatibility, and ability to act as a barrier, rather than diagnostic accuracy metrics typically found in AI/ML device studies.
Here's an analysis of the provided text, structured to address your specific points where applicable, and noting when information is not present or relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a quantitative, metric-based format as one might expect for a diagnostic device. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing various parameters and highlighting that the new device meets the same performance and safety standards established for the predicate.
The "Effectiveness" section offers the closest information to performance, focusing on mechanical integrity and barrier properties.
| Parameter (effectively "Acceptance Criteria") | CIV-Flex™ Holster Cover Performance (Reported Performance) |
|---|---|
| Intended Use / Indications for Use | Same as predicate, except adapted for mechanical breast biopsy reusable holster/cable assembly. Prevents contamination, allowing reprocessing. |
| Design | Same as predicate. One-piece, geometry conforming cover. |
| Material | Same as predicate. Polyurethane, thermoplastic. CIVCO trade name CIV-Flex™. Used for over 10 years. (Generally Recognized As Safe - GRAS for this context) |
| Manufacturing | Same as predicate. Extruded/blown thin film, cut/heat seal, packaged in Class 10,000 cleanroom. Sterile packaging per ANSI/AAMI/ISO 11607. Sterilized by ethylene oxide gas. |
| Quality Systems | Same as predicate. FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same as predicate. 100% EtO method validated per ANSI/AAMI/ISO 11135. SAL 10-6. |
| Device Body Contact Category | Same as predicate. Surface devices, intact skin/mucosal membranes/breached surfaces; limited contact duration (< 24 hours). |
| Safety (Biocompatibility) | Same as predicate. Non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic. Testing in accordance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP. |
| Effectiveness (Mechanical) | Material adequate for intended use during application, removal, and use. Strength and elastic characteristics same as ultrasound cover, allowing use without tearing or pinholing. Same cover thickness of 0.002". |
| Effectiveness (Barrier Properties) | Provides an effective barrier to the prevention of microbial migration (implies similar performance to predicate which demonstrated this using viral penetration protocol). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For this type of device (a protective cover), the "test set" would refer to the samples of the cover material or the covers themselves that underwent various physical, chemical, and biological tests. The document indicates "Mechanical testing for CIV-Flex™ Holster Covers has shown that the material is adequate..." and "Experience and testing has shown that polyurethane covers: ... Provides an effective barrier...", but it does not specify the number of samples or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is often found in the full test reports, which are not included in a 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable to this type of device submission. Ground truth is typically associated with diagnostic accuracy, where clinical experts (e.g., radiologists, pathologists) determine the true disease state for comparing against an AI algorithm's output. For a physical device like a sterile cover, "ground truth" is established through standardized laboratory tests (e.g., sterility testing, biocompatibility testing, physical strength tests), not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable to this type of device submission for the reasons outlined in point 3. Adjudication methods (like 2+1 or 3+1) are used in clinical studies to resolve disagreements among human readers/experts when establishing ground truth for diagnostic efficacy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable to this type of device submission. MRMC studies are used to evaluate the performance of diagnostic systems (often AI-assisted) by comparing multiple readers' interpretations of multiple cases. The CIV-Flex™ Holster Cover is a physical accessory, not a diagnostic tool or an AI-powered system, so such a study would not be relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This is not applicable to this type of device submission. This question pertains to AI/ML device performance, where "standalone" refers to the algorithm's performance without human interaction. The CIV-Flex™ Holster Cover is a physical medical device.
7. The Type of Ground Truth Used
For the CIV-Flex™ Holster Cover, the "ground truth" (or the basis for demonstrating safety and effectiveness) is established through:
- Standardized Sterility Testing: Validation using ANSI/AAMI/ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process) to achieve a SAL (Sterility Assurance Level) of 10-6.
- Biocompatibility Testing: In accordance with ISO 10993-Part 1 (Biological evaluation of medical devices), FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP), demonstrating non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity.
- Mechanical Testing: Demonstrating adequate strength and elasticity to prevent tearing or pinholing during application, removal, and use.
- Barrier Property Testing: Performance as an effective barrier to microbial migration, implicitly by being equivalent to the predicate device which had demonstrated this using a viral penetration protocol.
These are objective, laboratory-based metrics, not subjective expert consensus, pathology, or outcomes data in the clinical sense you might be referring to for diagnostic devices.
8. The Sample Size for the Training Set
This is not applicable to this type of device submission. The concept of a "training set" refers to data used to train an AI/ML algorithm. The CIV-Flex™ Holster Cover is a physical accessory and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
This is not applicable to this type of device submission for the same reasons as point 8.
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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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K002546 Page 274
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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CIVCO Medical Instruments 08/16/00
CIV-Flex™ Holster Cover
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Kov 2546 Page 3 of 4
Comparison of Device to Substantially Equivalent, Legally Marketed Device
| Parameter | CIV-Flex™ Holster Cover | Predicate DeviceCIVCO Poly UltrasoundTransducer Cover (K970513) |
|---|---|---|
| Intended Use /Indications forUse | Same, except subject device is amechanical breast biopsy reusableholster / cable assembly instead of anultrasound transducer. | A protective cover that helps preventscontamination [blood, body fluids,ultrasound gel, etc.] and thus allowingfor reprocessing of the device betweenpatient 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 BodyContact Category | Same. | surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (< 24 hours). |
| Parameter | CIV-Flex™ Holster Cover | Predicate DeviceCIVCO Poly UltrasoundTransducer Cover (K970513) |
| Safety | Same. | Biocompatibility tests for acute systemictoxicity, irritation, sensitization,hemolysis, material mediated pyrogen,and ethylene oxide sterilization residualshave demonstrated the polyurethane[CIV-Flex™] material / cover device is:non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with -ISO 10993-Part 1 Biological Evaluationof Medical Devices, FDA Blue BookMemorandum #G95-1, and FDA-GoodLaboratory Practices (GLP). |
| Effectiveness | Same.Mechanical testing for CIV-Flex™Holster Covers has shown that thematerial is adequate for the intendeduse:a) during application and removal ofcover from holster, b) during use asintended.Strength and elastic characteristicsare the same as that of theultrasound cover allowing usewithout tearing or pinholing. same cover thickness of .002". | Experience and testing has shown thatpolyurethane covers:polyurethane has sufficient strengthand elasticity for the intended use. Nominal cover thickness is .002". Provides an effective barrier to theprevention of microbial migration asdemonstrated using protocoladapted from that used to evaluatethe barrier properties / resistance ofsurgical gloves and endoscopesheaths to penetration bybloodborne pathogens using viralpenetration as a test method. |
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Koo 2546 Page 4 of 4
Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.
Page II - 4
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2000
Mr. J. William Jones Regulatory Affairs Manager CIVCO Medical Instruments Co, Inc. 102 First Street South KALONA IA 52247-9589
Re: K002546 CIVCO Medical, CIV-Flex™ Holster Cover Dated: August 16, 2000 Received: August 17, 2000 Regulatory Class: II 21 CFR §876.1075/Procode: 78 KNW
Dear Mr. Jones:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 problibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation regulatory action. Jn addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal faws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
K002546 510(k) Number (if known):
CIV-Flex™ Holster Cover Device Name:
Indications For Use:
A protective cover for a mechanical breast biopsy device reusable A procetive oover assembly that helps prevent contamination [blood, holor / Sablo assend gel, etc.] of the holster control buttons, and body flande, and as a reprocessing of the holster between patient uses; covers are single use, disposable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE 1F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Thos A. Serson
OR
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K002546
CIV-Flex™ Holster Cover
§ 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.