(49 days)
Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The cover allows use of the transdacer in Naming and intra-operative uitesound, while helping to proven transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.
The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include: General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.
The provided text describes a 510(k) submission for a Synthetic Polyisoprene Ultrasound Transducer Cover, arguing for its substantial equivalence to a legally marketed predicate device, the CIVCO NeoFlex™ Ultrasound Transducer Cover (K991236).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets for performance metrics (e.g., "tear strength > X MPa"). Instead, the criteria are qualitative and comparative, demonstrating that the new device performs "effectively similar" to the predicate device in key areas.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Synthetic Polyisoprene) |
|---|---|---|
| Intended Use / Indications for Use | Same as predicate device. | Same. (Provides a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments; helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer, and helps to maintain the sterile field where applicable; disposable device - for single patient/procedure use.) |
| Design | Same as predicate device (one- or two-piece, closed end, rolled or attached to polyethylene, various dimensional configurations to accommodate different transducers). | Same. |
| Material | Meet recommended safe levels of US FDA CFR, Title 21, Section 177.2600 and 182.5991. Not contain natural protein allergen residuals present in latex. | Polyisoprene, synthetic rubber. Materials meet recommended safe levels. Does not contain natural protein allergen residuals present in latex. |
| Manufacturing | Same as predicate device (dip-molding/rubber vulcanization, packaged in class 10,000 cleanroom per Federal Std 209e, packaging system per ANSI/AAMI/ISO 11607). | Same. |
| Quality Systems | Comply with FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. | Same. |
| Sterility | When applicable, achieve sterility by 100% EtO method, validated ANSI/AAMI/ISO 11135, with SAL 10-6. | Same. |
| Device Body Contact Category | Same as predicate device (surface devices, intact skin/mucosal membranes/breached surfaces; limited contact duration (< 24 hours); external communicating devices, tissue communicating; limited contact duration (< 24 hours)). | Same. |
| Safety (Biocompatibility) | Non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic. 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). | Biocompatibility tests for cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen, and ethylene oxide sterilization residuals have demonstrated the Synthetic Polyisoprene material/cover device is: non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic. Testing performed in accordance with specified standards. |
| Effectiveness (Strength & Elasticity) | Sufficient strength and elasticity to prevent tearing or pinholing during application/removal, during scanning, and during attaching/removing a disposable needle guide. Effectively similar to NeoFlex™. Nominal thickness of .010". | Testing showed that the material is adequate for the intended use: Strength and elastic characteristics are effectively similar to that of NeoFlex™ and allows use without tearing or pinholing the cover under various conditions. Nominal thickness of .010". |
| Effectiveness (Ultrasound Imaging) | Does not impair ultrasound imaging. | Ultrasound imaging is not impaired. |
| Effectiveness (Barrier to Microbial Migration) | Provides an effective barrier to the prevention of microbial migration, comparable to surgical gloves and endoscope sheaths against bloodborne pathogens (viral penetration as test system). | Synthetic Polyisoprene transducer cover provides an effective barrier to the prevention of microbial migration - tested under a 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 system. Synthetic Polyisoprene material is used for medical examination/surgical gloves. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific tests within an "effectiveness" study or "test set" in the context of clinical performance. Instead, it refers to "testing for Synthetic Polyisoprene covers" and "biocompatibility tests" demonstrating compliance with the criteria.
- Sample Size: Not specified.
- Data Provenance: Not specified. The studies appear to be laboratory-based and focused on material properties and barrier effectiveness. There's no mention of human subject data, clinical trials, or retrospective/prospective studies involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for the performance evaluation of this medical device (a transducer cover) is based on established scientific and engineering standards, material properties, and biological compatibility testing, not on expert consensus from clinical cases for diagnostic accuracy.
- Qualifications of Experts: Not specified. Given the nature of the evaluation, these would likely be material scientists, microbiologists, and engineers involved in the testing and validation processes.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of device evaluation does not involve diagnostic interpretation or clinical scenarios requiring adjudication of expert opinions. The assessment is based on objective measurements and compliance with standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess how AI impacts the performance of human readers on a set of clinical cases. The device in question is a physical medical accessory, not an AI algorithm.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, in a sense, the conducted studies for biocompatibility, strength, elasticity, and microbial barrier are "standalone" in that they evaluate the device's intrinsic properties without human-in-the-loop performance influencing the primary outcome metrics. This is not referring to "algorithm only" in the context of AI, but rather the device's physical and biological performance attributes.
7. The Type of Ground Truth Used
The "ground truth" for this device evaluation comprises:
- Biocompatibility Standards: Compliance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP) for non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity.
- Material Strength and Elasticity Specifications: Implicitly, the material must meet certain physical property thresholds (tensile strength, elongation, etc.) to ensure it doesn't tear or pinhole during use, as demonstrated by "effectively similar" performance to the predicate.
- Ultrasound Imaging Quality: The device must not "impair ultrasound imaging," which would be assessed objectively.
- Microbial Barrier Effectiveness: Demonstrated by testing "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 system."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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DEC 2 8 2001
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
(As required by 21 CFR 807.92)
Synthetic Polyisoprene Ultrasound Transducer Cover
A. General Information
| Submitter's Name: | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone (319) 656-4447 fax: (319) 656-4451 |
| Contact Person: | Theresa Leinen, Quality Systems Administrator |
Establishment Registration Number: 1937223 CIVCO Medical Instruments Co., Inc. is registered as a medical device manufacturer.
| Device Trade: | Synthetic Polyisoprene Ultrasound TransducerCover |
|---|---|
| Device Common: | Ultrasound Transducer Cover / Sheath / Drape |
| Device Classification Name: | Ultrasonic Diagnostic Transducer Accessories |
| Classification: | Class II under 21 CFR 892.1570 |
| Classification Panel: | Radiology |
| Classification Procode: | 90 ITX |
Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
B. Device Description
Classification Procode:
The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another.
The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)
Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)
Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip
Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.
Page II - 1
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K0/3721
2/5
C. Intended Use / Indications for Use
The Synthetic Polyisoprene Ultrasound Transducer Cover is a protective cover or sheath The Synthetic I virylsoprene Offransducer / probe / scanhead instruments. The cover is used with placed over an ultrasound transduor 7 probe Foody surface, endocavily, and the transdicer in Scanning and necule galadu procedured to rasound. The cover also helps to intra-operative ulagnostic, interventional; of the patient and healthcare in prevent transfer of the transducer (both sterile and non-sterile covers). The cover also
worker during reuse of the transducer (both sterile and non-sterile cover also worker dunny rease of the transadoes (secrile field (sterile covers only). Synthetic provides a means for maintenantes of a stonio ficial when treating a patient with known type I Polylsoprene is facex-free and therefore benoments. I sensitized. Transducer hypers are furnished sterile & non-sterile; single use patient / procedure, disposable.
The intended use and indications for use place Synthetic Polyisoprene Ultrasound The Intondou aso an in device body contact categories as follows:
- surface devices, intact skin / mucosal membranes / breached surfaces, a) limited contact duration (< 24 hours)
- external communicating devices, tissue communicating, b) limited contact duration (< 24 hours)
D. Predicate Device
The Synthetic Polyisoprene Ultrasound Transducer Cover is identified as substantially The Oynlinetic Torylooprono Shiracolly marketed NeoFlex™ Ultrasound Transducer Covers:
| Predicate Device(s) | 510(k) Reference | Manufacturer |
|---|---|---|
| NeoFlex™ Ultrasound Transducer Cover | K991236 | CIVCO |
E. Substantial Equivalence Summary
The Synthetic Polyisoprene Ultrasound Transducer Cover is substantially equivalent in The bynthetto I offectiveness to the CIVCO NeoFlex™ Ultrasound Transducer Cover. The salely and Shoutronooo following page demonstrates this substantial equivalence.
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K 013721
3/5
Comparison of Device to Substantially Equivalent, Legally Marketed Device
| Parameter | Synthetic PolyisopreneUltrasound Transducer Cover | Predicate DeviceCIVCO NeoFlex™ UltrasoundTransducer Cover (K991236) |
|---|---|---|
| Intended Use /Indications forUse | Same. | Provides a thin, conformal protectivecover system for ultrasound transducerusage in body surface, endocavity, andintra-operative patient environments;helps to prevent transfer ofmicroorganisms, body fluids, andparticulate material to the patient andhealthcare worker during reuse of thetransducer, and helps to maintain thesterile field where applicable;disposable device - for single patient /procedure use. |
| Design | Same. | One-piece, closed end, rolled (condomstyle) or a two-piece , closed endcover, (synthetic rubber attached topolyethylene) with various dimensionalconfigurations necessary toaccommodate differences in ultrasoundtransducer geometries. |
| Material | Polyisoprene, synthetic rubber Materials used in compounding meetthe recommended safe levels asspecified in the US Food and DrugsAdministration CFR, Title 21, Section177.2600 and 182.5991. USP Absorbable Dusting Powder. Synthetic rubber does not containthe natural protein allergen residualspresent in latex. | Polychloroprene, syntheticrubber Materials used in compoundingmeet the recommended safe levelsas specified in the US Food andDrugs Administration CFR, Title 21,Section 177.2600 and 182.5991. USP Absorbable Dusting Powder. Synthetic rubber does not containthe natural protein allergenresiduals present in latex. |
| Manufacturing | Same. | dip-molding / rubber vulcanization. packaged in class 10,000cleanroom per Federal Std 209e. packaging system perANSI / AAMI / ISO 11607. |
| Parameter | Synthetic PolyisopreneUltrasound Transducer Cover | Predicate DeviceCIVCO NeoFlex™ UltrasoundTransducer Cover (K991236) |
| Quality Systems | Same. | FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same. | sterilization (when applicable) by100% EtO method; validated ANSI / AAMI / ISO 11135. SAL 10-6. |
| Device BodyContact Category | Same. | surface devices, intact skin /mucosal membranes / breachedsurfaces;limited contact duration (< 24 hours) External communicating devices,tissue communicating;limited contact duration (< 24 hours) |
| Safety | Biocompatibility tests for cytotoxicity,acute systemic toxicity, irritation,sensitization, hemolysis, materialmediated pyrogen, and ethylene oxidesterilization residuals have demonstratedthe Synthetic Polyisoprene 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). | Biocompatibility tests for acute systemictoxicity, irritation, sensitization,hemolysis, material mediated pyrogen,and ethylene oxide sterilizationresiduals have demonstrated theNeoFlex™ 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). |
| Parameter | Synthetic PolyisopreneUltrasound Transducer Cover | Predicate DeviceCIVCO NeoFlex™ UltrasoundTransducer Cover (K991236) |
| Effectiveness | Testing for Synthetic Polyisoprenecovers has shown that the material isadequate for the intended use:Strength and elastic characteristicsare effectively similar to that ofNeoFlex™ and allows use withouttearing or pinholing the cover - a)during application and removal ofcover from transducer, b) duringscanning under intended uses, andc) attaching / removing a disposableneedle guide to the transducerbracket over the cover. Nominal thickness of .010". Ultrasound imaging is not impaired. Synthetic Polyisoprene transducercover provides an effective barrier tothe prevention of microbial migration- tested under protocol adapted fromthat used to evaluate the barrierproperties / resistance of surgicalgloves and endoscope sheaths topenetration by bloodbornepathogens using viral penetration asa test system. Synthetic Polyisoprene material isused for medical examination /surgical gloves. | Experience and testing has shown thatpolychloroprene (neoprene) covers:Neoprene has sufficient strengthand elasticity for the intendedapplication. Nominal thickness is .010". Does not impair ultrasound imaging. Are an effective barrier to theprevention of microbial migration. |
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K013721
4/5
Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.
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K0/3721
5/5
Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.
F. Conclusions
This premarket submission for the Synthetic Polyisoprene Ultrasound Transducer 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2001
Ms. Theresa Leinen Quality Systems Administrator CIVCO Medical Instruments Co., Inc. 102 First Street South KALONA IA 52247
Re: K013721
Trade/Device Name: Synthetic Polyisoprene Ultrasound Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: November 2, 2001 Received: November 9, 2001
Dear Ms. Leinen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to the enactment date of the Medical Device Amendments, or to conninered pror to that 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Costience Act (110) that do novice, subject to the general controls provisions of the Act. The Tou may, moreloro, manot and work include requirements for annual registration, listing of general controls provisions of the revelop, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (200 a00 a00 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 r teast of advised that I Driv institution that your device complies with other requirements of the Act that I Dr Hoss Intacted and regulations administered by other Federal agencies. You must or any I vathal beth steppirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 Or It I at 007), acoming (OS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by oversions (sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/5/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird in flight, composed of three curved lines.
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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
and the same of the same of the same of the same of the same of
| 510(k) Number (if known): | K013721 |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The Protective cover of sheath is placed over an unasounts in pocedures for body surface, endocarity, cover allows use of the transdacer in Naming and transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nancy Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013721 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ✓ |
Synthetic Polyisoprene
CIVCO Medical Instruments CO., Inc 02 November 2001
Synthetic Polyisoprene Ultrasound Transducer Cover
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.