K130758 · Kronner Prototypes, Inc. · LKF · Dec 11, 2013 · Obstetrics/Gynecology
Device Facts
Record ID
K130758
Device Name
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
Applicant
Kronner Prototypes, Inc.
Product Code
LKF · Obstetrics/Gynecology
Decision Date
Dec 11, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 2
Indications for Use
The Kronner Side-Kick is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. Caution: Federal law restricts this device to sale by or on the order of a physician.
Device Story
Kronner Side-Kick is a mechanical holder for uterine/vaginal manipulators used in laparoscopic/open gynecological surgery. Device mounts to standard OR tables; holds manipulators (e.g., RUMI, V-Care, Arch Koh) in position to reduce staff fatigue and free personnel. System consists of an arm assembly, gas supply module, and foot pedal. Gas supply module (connected to wall/portable nitrogen or compressed air) controls joint locking/unlocking. Foot pedal releases joints for positioning; releasing pedal locks joints. Device remains external to patient. Operated by trained OR personnel. Benefits include stable positioning of surgical instruments during procedures.
Clinical Evidence
Bench testing only. Factory testing confirmed compatibility with Arch Koh, RUMI, and V-Care manipulators, ability to move the uterus through required surgical ranges, holding strength, and ease of assembly in an OR environment.
Technological Characteristics
Materials: Aluminum and stainless steel. Energy source: Pneumatic (nitrogen or compressed air). Connectivity: None. Form factor: Articulated arm assembly with gas supply module and foot pedal. Sterilization: Not specified. Software: None.
Indications for Use
Indicated for holding uterine manipulators during laparoscopic or open surgery on female pelvic organs. Prescription use only.
Regulatory Classification
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.
Special Controls
*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.
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## DEC 1 1 2013
#### K130758
# 510(K) SUMMARY
as required by 807.92
Dec. 6, 2013 Date:
Kronner Prototypes, Inc. Submitter: 1443 Upper Cleveland Rapids Road Roseburg, OR 97471 Tel: (541- 672-2543
ER Number: 3018984
Contact:
Richard F. Kronner M.D. President Telephone: (541) 672-2543 Fax: (541) 672-1074 E-mail: kronner@rosenet.net ﺗ ﺘﺴﺒﻪ ﻧ
Subject Device:
Kronner Side-Kick Uterine Manipulator Holder
Common Name:
Trade Name:
Holder, Positioner, Arm, Instrument Guide
Classification Name:
no known industry name for this device
Device Class:
Unclassified (LKF)
Kronner Prototypes, Inc. Kronner Side-Kick uterine manipulator Holder
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### Predicate Device: Intuitive Surgical (K071405) marketed as: Coopers Uterine Positioning System by Coopersurgical K071405
#### Device Description:
The Kronner Side-Kick uterine manipulator holder is used to mount, position and hold
in position uterine or vaginal manipulators used in laparoscopic surgical procedures. It is made mostly from aluminum and stainless steel and is mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Sidek-Kick frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures.
The manipulator is inserted into the patient using standard technique, then the Side-Kick is joined to the manipulator.
With proper adapters the Side-Kick may be used with various manipulators, such as the RUMI, the V-Care and the Arch Koh,
A gas supply module, which can be attached to the operating table rail, transfers nitrogen or compressed air from the wall or a portable tank to the Side-Kick holder through two flexible lines. When the switch is turned on the Side-Kick joints are locked. When the switch is turned off the Side-Kick joints are unlocked.
Pressing a foot pedal releases all the Side-Kick joints for position changes. When the foot pedal is released the joints lock. The foot pedal is connected to the gas supply module through two lines covered by a protective hose.
A branched gas line connects the two luers of the Arm assembly to the gas supply module. A single gas line connects the gas supply module to the main pivot.
The Kronner Side-Kick remains external to the patient's body at all times.
#### Intended Use:
The Kronner Side-Kick is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
"Caution: Federal law restricts this device to sale by or on the order of a physician.
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#### Comparison to predicate device:
Based on the comparison of design, technology, materials, manufacturing, performance, specifications, and method of use, the Kronner Side-Kick is substantially equivalent to the previously identified pre-amendment and 510(k) cleared predicate device.
#### Technological Characteristics:
The technological characteristics of the subject device are the equivalent to the predicate devices.
#### Performance data:
Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject device is substantially equivalent to the predicate device cited, and that design output meets the design input requirements.
#### Conclusion:
Based upon available technical information, intended use and performance information provided in this pre-market notification, the Kronner Side-Kick described herein is substantially equivalent to current legally marketed pre-amendment and 510(k) cleared predicate devices.
### Kronner Sidekick Factory Testing
Kronner Sidekick and Sidekick uterine manipulator adapters are factory tested so they meet the following acceptance criteria:
1. That Arch Koh, RUMI, and V care manipulators can be attached to Sidekick adapters satisfactorally and can be used, as required, for the intended use .
2. That Arch Koh, RUMI, and V care manipulators will be able to move the uterus through a range required for the surgery.
3. That Arch Koh, RUMI, and V care manipulators will be held with the strength required for holding the uterus during the surgery.
4. That all Sidekick components will perform as required.
5. That all Sidekick components can be easily assembled in an operating room environment.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is in a bold, sans-serif font and is centered horizontally. The words are arranged on a single line and the text appears to be extracted from a document or a heading.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Kronner Prototypes, Inc. Richard F. Kronner, M.D. 1443 Upper Cleveland Rapids Road Roseburg, Oregon 97471
December 11, 2013
Re: K130758
Trade/Device Name: Kronner Side-Kick Uterine Manipulator Holder Regulatory Class: Unclassified Product Code: LKF Dated: October 23, 2013 Received: November 01, 2013
Dear Dr. Kronner:
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. Iisting 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Richard F. Kronner, M.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Joshua C. Nipper -S
Binita Ashar, MD, MBA, FACS For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## K130758
## Statement of Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Kronner Sidekick Uterine Manipulator Holder
Indications For Use:
නියෝගයේ පොහොත් පැවැති ප්රධාන අවස්ථානයේ ප්රධාන බවට පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පි
For holding uterine manipulators during laparoscopic or open surgery on female pelvic organs.
#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Prescription Use<br>(Per 21 CFR 801.109) | XX | OR | Over-The-Counter Use |
|------------------------------------------|----|----|----------------------|
|------------------------------------------|----|----|----------------------|
| Long H. Chen - A | for BSA |
|------------------------------|--------------------------|
| (Division Sign-off) | (Optional Format 1-2-96) |
| Division of Surgical Devices | |
| 510(k) Number: K130758 | |
5-1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
