(203 days)
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist Instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table 1 below. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Intuitive Surgical® Instrument and Accessory Sterilization Trays are intended only for use with Intuitive Surgical® EndoWrist Instruments and Intuitive Surgical Re-usable Accessories. These trays are used to enclose and hold the Instruments and Accessories in an organized manner during the sterilization process and subsequent storage and transportation. The trays are to be used with an approved sterilization wrap in order to maintain the sterility of the enclosed devices. The trays are different sizes of the same basic configuration: a rectangular base with latchable lids. The trays have perforations on the lid, bottom and sides to allow sterilant penetration. The bottom surface of the trays contains grooves custom made to fit and accommodate Intuitive Surgical® EndoWrist Instruments and Accessories. The grooves facilitate the Instruments and Accessory to be arranged in an organized manner when placed in the tray. The sterilization trays have been tested for use ONLY with the Intuitive Surgical® EndoWrist Instruments and Accessories for a sterilization cycle of Pre-Vac steam sterilization 132°C, 4min cycle with a 30 min dry time. This cycle parameter is similar to the current recommended sterilization cycle for the Intuitive Surgical® EndoWrist Instruments and Accessories.
Here's a breakdown of the acceptance criteria and study information for the Intuitive Surgical® Instrument and Accessory Sterilization Trays, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Intended for use ONLY with Intuitive Surgical® EndoWrist Instruments and Intuitive Surgical Re-usable Accessories. | The trays are specifically designed with grooves to fit and accommodate these instruments and accessories. |
| Designed to facilitate pre-vacuum autoclave sterilization process. | Sterilization validation testing was performed to demonstrate successful sterilization. |
| To be used in conjunction with an approved sterilization wrap. | The device description explicitly states: "The trays are to be used with an approved sterilization wrap in order to maintain the sterility of the enclosed devices." |
| Effective sterilization with a pre-vacuum cycle of 132°C, 4 minutes with a 30-minute dry time. | "Sterilization validation testing was performed to demonstrate successful sterilization... using a pre-vacuum cycle of 132°C, 4 mins with a 30 min dry time." |
| Maintain organization and protection of instruments/accessories during sterilization, storage, and transport. | The device description states: "These trays are used to enclose and hold the Instruments and Accessories in an organized manner during the sterilization process and subsequent storage and transportation." |
| Made of standard medical-grade materials. | "The trays are made of standard medical grade materials..." |
| Comparable functional characteristics to predicate devices. | "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size for the sterilization validation testing in numerical terms (e.g., "N=X sterilization cycles were performed"). It states that "Sterilization validation testing was performed."
- Data Provenance: Not explicitly stated, however, the process described (sterilization validation testing for a medical device) typically involves in-house laboratory testing or 3rd party laboratory testing specifically for regulatory submission, rather than clinical data from a country of origin. It is prospective testing designed to prove the device's function.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document describes "sterilization validation testing," but it does not detail the methodology for establishing a "ground truth" through expert review, as would be typical for diagnostic devices. For a sterilization tray, the "ground truth" would be the successful sterility of the instruments, determined by standard microbiological testing methods, rather than expert interpretation of images or other data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the device is a sterilization tray, not a diagnostic device requiring adjudication of human-interpreted results. The "test set" relates to the successful sterilization outcome, which is determined by objective laboratory methods, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable/not provided. The device is an instrument sterilization tray, not an artificial intelligence (AI) diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. As stated, this is a physical medical device (sterilization tray), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device would be the microbiological sterility of the instruments and accessories after undergoing the validated sterilization cycle within the tray. While not explicitly detailed, standard sterilization validation involves biological indicators and microbiological testing to confirm the absence of viable microorganisms.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
{0}------------------------------------------------
Section II
:
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K072211
| Date | Feb 11, 2008 |
|---|---|
| Submitter | Intuitive Surgical®, Inc.950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Michael YramateguiSr. Director, Regulatory & Quality AffairsTelephone: (408) 523 - 2145 ; Fax: (408) 523 - 1390E-mail: mike.yramategui@intusurg.com |
| SubjectDevice | Trade Name(s):Intuitive Surgical® Instrument and Accessory SterilizationTraysClassification Name:Sterilization wrap containers, trays, cassettes & otherAccessory (21CFR §880.6850)Common Name:Sterilization Cassettes, Instrument Tray, Sterilization Tray,Instrument Delivery SystemDevice Class:Class II (KCT) |
| PredicateDevices | PolyVac Surgical Instrument Delivery System (K012105)Poly Vac Inc.Paragon Medical Surgical Instrument Delivery System(K032119)Paragon Medical, Inc. |
| PredicateDevices (Cont.) | Olympus Sterilization Trays (K033222)Olympus Winter & Ibe |
| DeviceDescription | Intuitive Surgical® Instrument and Accessory SterilizationTrays are intended only for use with Intuitive Surgical®EndoWrist Instruments and Intuitive Surgical Re-usableAccessories. These trays are used to enclose and hold theInstruments and Accessories in an organized manner duringthe sterilization process and subsequent storage andtransportation. The trays are to be used with an approvedsterilization wrap in order to maintain the sterility of theenclosed devices.The trays are different sizes of the same basic configuration: arectangular base with latchable lids. The trays haveperforations on the lid, bottom and sides to allow sterilantpenetration. The bottom surface of the trays contains groovescustom made to fit and accommodate Intuitive Surgical®EndoWrist Instruments and Accessories. The groovesfacilitate the Instruments and Accessory to be arranged in anorganized manner when placed in the tray.The sterilization trays have been tested for use ONLY with theIntuitive Surgical® EndoWrist Instruments and Accessoriesfor a sterilization cycle of Pre-Vac steam sterilization 132°C,4min cycle with a 30 min dry time. This cycle parameter issimilar to the current recommended sterilization cycle for theIntuitive Surgical® EndoWrist Instruments and Accessories. |
| IntendedUse | Intuitive Surgical Instrument and Accessory SterilizationTrays are intended for the protection, organization anddelivery to the surgical field of Intuitive Surgical EndoWristInstruments and Intuitive Surgical Re-usable AccessoriesONLY, as listed in Table 1 below. |
{1}------------------------------------------------
TABLE 1: List of Compatible Devices
| INTENDED CONTENT | DESCRIPTION |
|---|---|
| Intuitive SurgicalEndoWrist Instruments | da Vinci & da Vinci S families of8mm & 5mm EndoWrist Instruments |
| Intuitive Surgical Re-usableAccessories | da Vinci and da Vinci S families of8mm & 5mm accessories includingcannulae, obturators, cannula mount,sterile adapters etc |
{2}------------------------------------------------
Intended Use The trays are not intended to maintain sterility by themselves. (Cont.) They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Autoclave Sterilization Parameter:
- Cycle: Pre-vacuum Temperature: 270-272°F (132-134°C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins
Table 2 provides description of 4 configurations of Intuitive Surgical Instrument and Accessory Sterilization Trays
| TRAYNAME | INTENDEDCONTENT(Intuitive SurgicalEndoWristInstruments andIntuitive SurgicalRe-usableAccessories ONLY) | DIMENSION(Inches)L x W x H | WEIGHT(Pounds)UL:UnloadedFL: FullyLoaded |
|---|---|---|---|
| SingleInstrumentTray (P/N400220) | One EndoWristInstrument | 24.1" x 9.7" x3.5" | UL: 1 lbFL: 2 lb |
| InstrumentTray (P/N400221) | Eight EndoWristInstruments | 24.1" x 9.7" x3.5" | UL: 1 lbFL: 2 lb |
| AccessoryTray (P/N400222) | Accessories | 21.1" x 9.7" x3.5" | UL: 5 lbFL: 13 lb |
| ProcedureTray (P/N400223) | Eight EndoWristInstruments &Accessories | 24.1" x 9.7" x5.5" | UL: 7 lbFL: 21 lb |
TABLE 2: Intuitive Surgical Instrument and Accessory Sterilization Trays
Comparison to Predicate Device
Based on the comparison of design, technology, materials, manufacturing, performance, specifications, and method of use, the Intuitive Surgical® Instrument and Accessory Sterilization Trays are substantially equivalent to the identified 510(k) cleared predicate devices.
{3}------------------------------------------------
| TechnologicalCharacteristics | The technological characteristics of the subject devices areequivalent to the predicate devices. The trays are made ofstandard medical grade materials are don't incorporate anynew technological characteristics. |
|---|---|
| PerformanceData | Design analysis and testing has been conducted to confirmthat basic functional characteristics of the subject devices aresubstantially equivalent to the predicate devices cited, andthat design output meets the design input requirements.Sterilization validation testing was performed to demonstratesuccessful sterilization of the Intuitive Surgical® EndoWristInstruments and Intuitive Surgical Re-usable Accessorieswhen enclosed in the sterilization trays and sterilized using apre-vacuum cycle of 132°C, 4 mins with a 30 min dry time. |
| Conclusion | Based upon available technical information, intended use andperformance information provided in this pre-marketnotification, the Intuitive Surgical® Instrument and AccessorySterilization Trays described herein are substantiallyequivalent to current legally marketed predicate devices. |
:
:
:
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 28 2008
Intuitive Surgical, Incorporated C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 455 East Trimble Road San Jose, California 95131-1230
Re: K072211
Trade/Device Name: Intuitive Surgical® Instrument and Accessory Sterilization Trays Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 14, 2008 Received: February 15, 2008
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{5}------------------------------------------------
Page 2 - Mr. Morten
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Clive
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): K072211
Device Name: Intuitive Surgical® Instrument and Accessory Sterilization Trays
Indications for Use:
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table 1 below.
| INTENDED CONTENT | DESCRIPTION |
|---|---|
| Intuitive SurgicalEndo Wrist Instruments | da Vinci & da Vinci S familiesof 8mm & 5mm EndoWristInstruments |
| Intuitive Surgical Re-usableAccessories | da Vinci and da Vinci S familiesof 8mm & 5mm accessoriesincluding cannulae, obturators,cannula mount, sterile adaptersetc |
TABLE 1: List of Compatible Devices
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
ponents. Shila M Murphy
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 2
{7}------------------------------------------------
Autoclave Sterilization Parameter:
Cycle: Pre-vacuum Temperature: 270-272°F (132-134°C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins
Table 2 provides the description of the 4 configurations of the Intuitive Surgical Instrument and Accessory Sterilization Trays
| TRAY NAME | INTENDED CONTENT (IntuitiveSurgical EndoWristInstruments andIntuitive Surgical Re-usable AccessoriesONLY) | DIMENSION(Inches)L x W x H | WEIGHT(Pounds)UL: UnloadedFL: FullyLoaded |
|---|---|---|---|
| SingleInstrument Tray(P/N 400220) | One EndoWristInstrument | 24.1" x 9.7" x3.5" | UL: 1 lbFL: 2 lb |
| Instrument Tray(P/N 400221) | Eight EndoWristInstruments | 24.1" x 9.7" x3.5" | UL: 1lbFL: 2 Ib |
| Accessory Tray(P/N 400222) | Accessories | 21.1" x 9.7" x3.5" | UL: 5 IbFL: 13 Ib |
| Procedure Tray(P/N 400223) | Eight EndoWristInstruments &Accessories | 24.1" x 9.7" x5.5" | UL: 7 IbFL: 21 lb |
TABLE 2: Intuitive Surgical Instrument and Accessory Sterilization Trays
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use__X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).