(203 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of sterilization trays for surgical instruments. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No.
The device is a sterilization tray intended to hold surgical instruments and accessories during sterilization, storage, and transportation. It does not directly treat or diagnose a disease or condition.
No
This device is a sterilization tray for surgical instruments, designed to protect and facilitate the sterilization process, not to diagnose medical conditions.
No
The device description clearly describes physical sterilization trays made of a rectangular base with latchable lids and perforations, designed to hold and organize surgical instruments during sterilization. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the protection, organization, and delivery of surgical instruments and accessories to the surgical field, and to facilitate the sterilization process. This is a function related to surgical procedures and instrument handling, not diagnostic testing performed on samples taken from the human body.
- Device Description: The description details a physical tray designed to hold and organize surgical instruments during sterilization and transport. It focuses on features that allow for proper sterilization and organization of these instruments.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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. 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.
Autoclave Sterilization Parameter:
Cycle: Pre-vacuum Temperature: 270-272°F (132-134°C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
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)
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, and that design output meets the design input requirements.
Sterilization validation testing was performed to demonstrate successful sterilization of the Intuitive Surgical® EndoWrist Instruments and Intuitive Surgical Re-usable Accessories when enclosed in the sterilization trays and sterilized using a pre-vacuum cycle of 132°C, 4 mins with a 30 min dry time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Michael Yramategui |
| Sr. Director, Regulatory & Quality Affairs | |
| Telephone: (408) 523 - 2145 ; Fax: (408) 523 - 1390 | |
| E-mail: mike.yramategui@intusurg.com | |
| Subject | |
| Device | Trade Name(s): |
| Intuitive Surgical® Instrument and Accessory Sterilization | |
| Trays |
Classification Name:
Sterilization wrap containers, trays, cassettes & other
Accessory (21CFR §880.6850)
Common Name:
Sterilization Cassettes, Instrument Tray, Sterilization Tray,
Instrument Delivery System
Device Class:
Class II (KCT) |
| Predicate
Devices | PolyVac Surgical Instrument Delivery System (K012105)
Poly Vac Inc.
Paragon Medical Surgical Instrument Delivery System
(K032119)
Paragon Medical, Inc. |
| Predicate
Devices (Cont.) | Olympus Sterilization Trays (K033222)
Olympus Winter & Ibe |
| Device
Description | 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. |
| Intended
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. |
1
TABLE 1: List of Compatible Devices
| INTENDED CONTENT | DESCRIPTION |
|---|---|
| Intuitive Surgical | |
| EndoWrist Instruments | da Vinci & da Vinci S families of |
| 8mm & 5mm EndoWrist Instruments | |
| Intuitive Surgical Re-usable | |
| Accessories | da Vinci and da Vinci S families of |
| 8mm & 5mm accessories including | |
| cannulae, 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
| TRAY
NAME | INTENDED
CONTENT
(Intuitive Surgical
EndoWrist
Instruments and
Intuitive Surgical
Re-usable
Accessories ONLY) | DIMENSION
(Inches)
L x W x H | WEIGHT
(Pounds)
UL:
Unloaded
FL: Fully
Loaded |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------|
| Single
Instrument
Tray (P/N
400220) | One EndoWrist
Instrument | 24.1" x 9.7" x
3.5" | UL: 1 lb
FL: 2 lb |
| Instrument
Tray (P/N
400221) | Eight EndoWrist
Instruments | 24.1" x 9.7" x
3.5" | UL: 1 lb
FL: 2 lb |
| Accessory
Tray (P/N
400222) | Accessories | 21.1" x 9.7" x
3.5" | UL: 5 lb
FL: 13 lb |
| Procedure
Tray (P/N
400223) | Eight EndoWrist
Instruments &
Accessories | 24.1" x 9.7" x
5.5" | UL: 7 lb
FL: 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
| Technological
Characteristics | The technological characteristics of the subject devices are
equivalent to the predicate devices. The trays are made of
standard medical grade materials are don't incorporate any
new technological characteristics. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data | 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, and
that design output meets the design input requirements.
Sterilization validation testing was performed to demonstrate
successful sterilization of the Intuitive Surgical® EndoWrist
Instruments and Intuitive Surgical Re-usable Accessories
when enclosed in the sterilization trays and sterilized using a
pre-vacuum cycle of 132°C, 4 mins with a 30 min dry time. |
| Conclusion | Based upon available technical information, intended use and
performance information provided in this pre-market
notification, the Intuitive Surgical® Instrument and Accessory
Sterilization Trays described herein are substantially
equivalent 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 Surgical | |
| Endo Wrist Instruments | da Vinci & da Vinci S families |
| of 8mm & 5mm EndoWrist | |
| Instruments | |
| Intuitive Surgical Re-usable | |
| Accessories | da Vinci and da Vinci S families |
| of 8mm & 5mm accessories | |
| including cannulae, obturators, | |
| cannula mount, sterile adapters | |
| etc |
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 (Intuitive
Surgical EndoWrist
Instruments and
Intuitive Surgical Re-
usable Accessories
ONLY) | DIMENSION
(Inches)
L x W x H | WEIGHT
(Pounds)
UL: Unloaded
FL: Fully
Loaded |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------|
| Single
Instrument Tray
(P/N 400220) | One EndoWrist
Instrument | 24.1" x 9.7" x
3.5" | UL: 1 lb
FL: 2 lb |
| Instrument Tray
(P/N 400221) | Eight EndoWrist
Instruments | 24.1" x 9.7" x
3.5" | UL: 1lb
FL: 2 Ib |
| Accessory Tray
(P/N 400222) | Accessories | 21.1" x 9.7" x
3.5" | UL: 5 Ib
FL: 13 Ib |
| Procedure Tray
(P/N 400223) | Eight EndoWrist
Instruments &
Accessories | 24.1" x 9.7" x
5.5" | UL: 7 Ib
FL: 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)