(28 days)
No
The description focuses on the electromechanical nature of the device and its physical manipulation capabilities, with no mention of AI or ML.
No
The device is described as assisting surgical staff in mounting, positioning, and holding uterine manipulators, not directly treating a condition or disease.
No
The device is described as an assistive system for holding and positioning uterine manipulators during surgery, not for diagnosing conditions.
No
The device description explicitly states it is an "electromechanical device" consisting of a "single, multi-segmented, articulated arm" that attaches to an operating room table. This clearly indicates a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures." This describes a surgical assist device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a mechanical arm that attaches to an operating table to hold and position a surgical instrument (uterine manipulator). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device's function is purely mechanical support and positioning during a surgical procedure.
N/A
Intended Use / Indications for Use
The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
Product codes
LKF
Device Description
The ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.
The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operating room personnel in an operating room environment.
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 control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) were performed. The ALLY II UPS was tested to identified verification and validation activities including tests comparing the subject device to the predicate ALLY UPS - K141523.
Studies conducted:
- Durability (Useful Life) testing
- Holding force testing
- Range of motion testing
- Link Soak testing
- Foot Pedal Cable Retention Justification
The device is compliant with the following standards:
- IEC 60601-1: 2005+AMD1:2012+AMD2:2020 CSV Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: 2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance
Key Results: The subject ALLY II UPS met the pre-determined acceptance criteria for each intended output.
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
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological 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 § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2022
CooperSurgical, Inc. Yin Huang Regulatory Affairs Specialist 95 Corporate Drive Trumbull, CT 06611
Re: K223064
Trade/Device Name: ALLY II UPSTM (Uterine Positioning System) Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 28, 2022 Received: September 30, 2022
Dear Yin Huang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223064
Device Name ALLY II UPSTM (Uterine Positioning System)
Indications for Use (Describe)
The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary – K223064 ALLY II UPS™ (Uterine Positioning System)
I. Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 | |
| Telephone: 203-601-5200 | |
| Contact Person: | Yin Huang |
| Regulatory Affairs Specialist | |
| Date Prepared: | October 27, 2022 |
| II. Device Information: |
| Trade Name: | ALLY II UPS™ (Uterine Positioning System) |
|---|---|
| Common Name: | Uterine positioning system |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Regulation Number: | 884.4530 |
| Regulatory Class: | II |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |
III. Predicate Device Information:
ALLY Uterine Positioning System™ (K141523), manufactured by CooperSurgical Inc. The predicate device has not been subject to a design-related recall
IV. Device Description:
4
The ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.
The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.
The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.
V. Indications for Use:
The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
VI. Comparison of Technological Characteristics with the Predicate Device
A comparison of the intended use and technological characteristics of the subject and predicate device are included in the table below.
5
| Attribute | Predicate | Subject | Comparison |
|---|---|---|---|
| ALLY Uterine | ALLY II UPSTM | ||
| Positioning System | (Uterine Positioning | ||
| (UPS) - K141523 | System) | ||
| Principles of Operation | The ALLY II UPSTM | ||
| (Uterine Positioning | |||
| System) is intended to | |||
| assist the surgical staff in | |||
| mounting, positioning, | |||
| and holding uterine | |||
| manipulators during | |||
| gynecological | |||
| laparoscopic surgical | |||
| procedures. It is intended | |||
| for use by trained | |||
| operating room personnel | |||
| in an operating room | |||
| environment. | The ALLY II UPSTM | ||
| (Uterine Positioning | |||
| System) is intended to | |||
| assist the surgical staff in | |||
| mounting, positioning, | |||
| and holding uterine | |||
| manipulators during | |||
| gynecological | |||
| laparoscopic surgical | |||
| procedures. It is intended | |||
| for use by trained | |||
| operating room personnel | |||
| in an operating room | |||
| environment. | Identical | ||
| Sterilization | Non-sterile | Non-sterile | Identical |
| Range of motion | When the device is | ||
| attached to the operating | |||
| table bed rail: |
Anteverted hand position
- The distal tip of the
uterine manipulator
attached to the device can
reach the:
Anteverted hand
position can
manipulate to
designated 6
points of
extensionRetroverted hand position - Not Applicable | When the device is
attached to the operating
table bed rail:
Anteverted hand position
- The distal tip of the
uterine manipulator
attached to the device can
reach the:
Anteverted hand
position can
manipulate to
designated 6
points of
extensionRetroverted hand position
=
Retroverted hand position
is able to manipulate to
designated 5 points of
extension | Different:
The subject device has
greater Range of Motion
than the predicate. The
Range of Motion
difference does not raise
different questions of
S&E. |
| Rotation angle of the
Elbow | None – elbow is fixed at
50° toward sagittal plane
of patient | Rotate 70° away from the
sagittal plane of patient | Different:
The subject device has
greater Range of Motion
than the predicate. The
Elbow rotation difference
does not raise different
questions of S&E. |
| Material(s) of the arm
LINKS | 303 stainless Steel | 17-4 stainless steel | Different: |
| | | | This modification allows
for a longer useful life of
the Flexible Arm for the
subject device than the
predicate The material
change does not raise
different questions of
S&E |
| PEEK Inserts in the
LINKS and Elbow | No protective inserts over
actuator cable | Additional inserts to
provide a protective
barrier for the cable | Different: |
| | | | This modification allows
for a longer useful life of
the Flexible Arm for the
subject device than the
predicate. The PEEK
insert in the LINKs does
not raise different
questions of S&E |
| Foot pedal connection to
device | Hard wired to device -
undetachable | Connector can be
detachable | Different: |
| | | | The subject device
provides more
convenience for users
than the predicate by
allowing ease of mobility
and packing of the device
in moving the unit around
the hospital. The
detachable connection
does not raise different
questions of S&E |
| Grounding Post | None | Attached to bottom of
device as a built-in feature
for grounding the device | Different: |
| | | | The Grounding Post is
added as an additional
grounding option for
hospitals when they have
concerns over electrical
grounding within the
hospital setting.
The Grounding Post does
not raise different
questions of S&E |
| Handle | Flat plate with finger
holding | Whole hand handle | Different: |
| | | | This modification was
made as an ergonomic
change to provide more
user convenience |
6
7
The subject ALLY II UPS has the same Intended Use, fundamental scientific technology, and similar materials as the predicate device. The subject device has an identical principle of operation and similar design to the predicate device.
The minor design changes for user convenience consist of:
-
- Improvement to the range of motion of the flexible arm to give users more flexibility in positioning uterine manipulators during gynecological laparoscopic surgical procedures.
-
- Minor modifications to the design features of the flexible arm to aid in flexibility, durability, and cleaning of the device.
-
- Addition of a detachable foot pedal connection where the predicate device was hard wired into the unit.
The changes in technological characteristics do not raise different questions of safety and effectiveness.
VII. Performance Data
The support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) was performed. The ALLY II UPS was tested to identified verification and validation activities including tests comparing the subject device to the predicate ALL Y UPS -K141523.
- Durability (Useful Life) testing .
- . Holding force testing
- Range of motion testing ●
- . Link Soak testing
- . Foot Pedal Cable Retention Justification
The device is compliant with the following standards:
IEC 60601-1: 2005+AMD1:2012+AMD2:2020 CSV Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
8
IEC 60601-1-2: 2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance
The subject ALLY II UPS met the pre-determined acceptance criteria for each intended output. Therefore, design verification testing determined that the subject ALLY II UPS is substantially equivalent to the identified predicate device.
VIII. Conclusion
The results of the testing described above demonstrate that the ALLY II UPS™ (Uterine Positioning System) is as safe and effective as the predicate device and supports a determination of substantial equivalence.