K071405 · Intuitive Surgical, Inc. · LKF · Oct 9, 2007 · Obstetrics/Gynecology
Device Facts
Record ID
K071405
Device Name
PROBE HOLDER SYSTEM
Applicant
Intuitive Surgical, Inc.
Product Code
LKF · Obstetrics/Gynecology
Decision Date
Oct 9, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 2
Indications for Use
The Probe Holder System 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.
Device Story
Probe Holder System; mechanical device for mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgery. System attaches to standard operating room tables; features jointed links, crossbar, and rail clamps at distal end; proximal end uses sterile adaptors to grasp surgical devices. Surgeon uses handle and foot pedal-actuated mechanism for intra-operative re-positioning. Device remains external to patient; covered by sterile drapes. Reduces staff fatigue; maintains device position for extended periods; frees staff for other tasks.
Clinical Evidence
Bench testing only. Design analysis and testing conducted to confirm functional characteristics are equivalent to predicate devices and meet design input requirements.
Technological Characteristics
Mechanical positioning system; jointed links, crossbar, rail clamps, and foot pedal-actuated mechanism. External use only; sterile drape coverage. No electronic or software components described.
Indications for Use
Indicated for use by trained operating room personnel to assist in mounting, positioning, and holding a uterine manipulator during gynecological laparoscopic surgical procedures.
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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Page 8 of 78
OCT - 9 2007
Ko71405
# 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.
## May 18, 2007 Date ースの出品を持つ。 1972年 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 1972 Intuitive Surgical, Inc. Submitter 950 Kifer Road Sunnyvale, CA 94086 ER Number 2955842 の回出した。 A H H H H H S A S - A M M F F A C - A M M F F C - F - F - F - F - F - F - F - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Michael Yramategui Contact Sr. Director, Regulatory & Quality Affairs Telephone: (408) 523 - 2145 Fax: (408) 523 - 1390 E-mail: mike.yramategui@intusurg.com Trade Name(s): Subject Device Probe Holder System Classification Name: Endoscope and Accessories (GCJ, §876.1500) Cannula, manipulator/injector, uterine (LKF,unclassified) Common Name: Holder, Manipulator, Positioner, Arm Device Class: Probe Holder System Class II (GCJ); Unclassified (LKF)
#### 510(k) Number:
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| Predicate<br>Devices | Endoboy (K033644)<br>Geyser, SA |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Zinnanti Uterine Manipulator/Injector (K941458)<br>Zinnanti Surgical Devices, Chatsworth, CA |
| | Mediflex Flex Arm (Pre-amendments device)<br>Islandia, NY |
| | Thompson Retractor/Device Holder (Pre-amendments device)<br>Traverse City, MI |
| Device<br>Description | The Intuitive Surgical Probe Holder System is used to mount,<br>position and hold in position uterine manipulators used in<br>laparoscopic surgical procedures. |
| | The Probe Holder System can be mounted to standard<br>operating room tables and locked in position allowing surgical<br>devices to be securely held in position for long periods of time.<br>Use of the Probe Holder System frees operating room staff for<br>other activities and reduces fatigue associated with manually<br>maintaining a device in position during surgical procedures. |
| | The Probe Holder System consists of two attachment mechanisms:<br>one at its distal terminus for mounting the system to the operating<br>room table and the other at the proximal terminus for securely<br>grasping a surgical device. The mechanism at the distal terminus<br>consists of jointed links, a crossbar and rail clamps while that at the<br>proximal end is a simple mechanism for affixing detachable sterile<br>adaptors that securely grasp a surgical device in the desired<br>position. A handle and foot pedal actuated-mechanism facilitates<br>rapid and secure intra-operative re-positioning of the device by the<br>surgeon as needed. |
| | The Probe Holder System remains external to the patient's body at<br>all times and is covered intra-operatively by sterile draping. |
| Intended<br>Use | The Probe Holder System is intended to assist the surgical staff in<br>mounting, positioning and holding a uterine manipulator during<br>gynecological laparoscopic surgical procedures. It is intended for<br>use by trained operating room personnel in an operating room<br>environment. |
CONFIDENTIAL
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______________________________________________________________________________________________________________________________________________________________________________
| Comparison to<br>Predicate Device | Based on the comparison of design, technology, materials,<br>manufacturing, performance, specifications, and method of use, the<br>Probe Holder System is substantially equivalent to the previously<br>identified pre-amendment and 510(k) cleared predicate devices. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The technological characteristics of the subject devices are the<br>equivalent to the predicate devices. |
| Performance Data | Design analysis and testing has been conducted to confirm that basic<br>functional characteristics of the subject devices are substantially<br>equivalent to the predicate devices cited, and that design output<br>meets the design input requirements. |
| Conclusion | Based upon available technical information, intended use and<br>performance information provided in this pre-market notification,<br>the Probe Holder System described herein is substantially<br>equivalent to current legally marketed pre-amendment and 510(k)<br>cleared predicate devices. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a simple, stylized manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2007
Intuitive Surgical, Inc. % Mr. Michael Yramategui Sr. Director, Regulatory & Quality Affairs 950 Kifer Road Sunnyvale, California 94086
Re: K071405
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LKF Dated: September 6, 2007 Received: September 7, 2007
Dear Mr. Yramategui:
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.
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 (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 - Mr. Michael Yramategui
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Section III
## Indications for Use
510(k) Number (if known): Ko71405
Intuitive Surgical® Endoscopic Instrument Control System Device Name:
Indications For Use:
The Probe Holder System 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Milken
al. Restorative, Division of Ge and Neurologica
510(k) Number
Page 1 of 1
Intuitive Surgical® Inc. Probe Holder System
CONFIDENTIAL
Traditional 510(k) Section III, Page 1 of 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.
