The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
Device Story
Movable, caster-mounted stretcher; includes side rails, fluid infusion equipment supports, and patient scale. Features twin-hydraulic cylinder lift system for height adjustment and Trendelenburg positioning. Intellidrive® option adds battery-powered drive mechanism integrated into platform; provides propulsion along floor with minimal caregiver force. Used in hospitals, surgical centers, and patient care facilities; operated exclusively by healthcare personnel via transport handles. Powered drive aids in patient transport, reducing physical strain on caregivers. Device does not allow patient control of propulsion.
Clinical Evidence
Bench testing only. No clinical data presented. Verification and validation performed on system and module levels to ensure design requirements and hazard mitigation. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) confirmed.
Technological Characteristics
Caster-mounted stretcher with twin-hydraulic cylinder lift system. Battery-powered drive mechanism. Meets UL 60601-1, CAN/CSA C22.2 601.1-M90, IEC 60601-1, IEC 60601-1-4, IEC 60601-2-38, and IEC 60601-1-2 standards. Programmable electrical medical system.
Indications for Use
Indicated for use by caregivers to assist in the treatment and transportation of patients within hospitals, surgical centers, and patient care facilities. No specific patient age, gender, or disease state contraindications are listed.
Regulatory Classification
Identification
A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).
Special Controls
(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.
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K112502.
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Device Owner:
Hill-Rom Company 1069 State Route 46 East Batesville, Indiana 47006
Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
#### 510(k) Summary Hill-Rom Procedural Stretcher with Intellidrive®
SEP 1 9 2011
Hill-Rom, Inc. 1069 State Route 46 East Batesville, IN 47006-9167 Phone: 812-934-777
Contact: Chad Hodson (812)-934-1278 Fax: (812)-931-3481 Registration Number: 1824206
Date Summary Prepared: 6/30/11
#### Device Names:
Trade Name: Hill-Rom Procedural Stretcher with Intellidrive® Common Name: Powered stretcher Classification Name: Stretcher, Wheeled, Powered, (21 CFR 890.3690, Product Code INK)
#### Regulatory Class: Class II
Predicate Devices: Stryker Powered Wheeled Stretcher, #K022309
Device Description: The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.
The Hill-Rom Procedural Stretcher with Intellidrive® meets the requirements of IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). The device carries the ETL marking to UL60601-1 and CAN/CSA C22.2 NO, 601.1-M90.
Intended Use: The Hill-Rom Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive® Transport System is a permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
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Hill.Rom Comnany 1069 State Route 46 East Batesville, Indiana 47006
# Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
# Similarities and Differences:
The Hill-Rom Procedural Stretcher with Intellidrive® is substantially equivalent in function and intended use to the Stryker® Powered Wheeled Stretcher. Each is intended to provide assistance to caregivers in the treatment and transportation of patients in healthcare facilities.
The predicate device is a Class II device, classified at 21 C.F.R. and 890.3690, Stretcher, Wheeled, Powered, Product Code INK. This is the same classification as the device being submitted.
As with the predicate device, this product is a movable, caster-mounted stretcher. Both products have side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. In both products, the addition of a powered transport mechanism to a normal transport stretcher enables the caregiver to move the stretcher with very little applied force.
Hazards for the product were identified in a systematic manner. A list of known or foreseeable hazards associated with the product both in normal and fault conditions was compiled and evaluated. A comprehensive review of field complaints, MDR's and recalls from similar Hill-Rom products and the predicate device was conducted and included in the hazard identification process. This review was conducted by a cross-functional team composed of members from Engineering, Quality, Regulatory Affairs, and Clinical.
A verification and validation plan has been developed that defines the testing parameters that ensure that the product meets its design requirements and that the hazards that were identified were eliminated by design features or that the occurrence rate is a low as reasonably possible. The testing was conducted on both a system level, with the system being the entire stretcher, and a module level, with the module being the Intellidrive mechanism. Safety and performance characteristics of the device were identified via customer needs and functional requirements of the device. The characteristics were converted into requirements that were verified and validated successfully. The product also successfully meets the following voluntary standards:
Medical Electrical Equipment: Part 1: General Requirements for Safety - UL 60601-1 (1st Ed., 25-Apr-03, Rev 26-Apr-06);
Medical Electrical Equipment: Part 1: General Requirements for Safety - General Instruction No. 1 - CAN/CSA C22.2 601.1-M90 (1st Ed., Nov-90, R2005) + Supplement No. 1-94 (C22.2 No. 601.1S1-94, Feb-94, R1999) + Amendment 2:1998 (Feb-98, R2006) + Update No. 2 (Nov-03, R2005);
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment 1, 1991-11, Amendment 2, 1995. (General);
IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
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Hill-Rom Company 1069 State Route 46 East Batesville, Indiana 47006
# Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
IEC 60601-2-38 1996/Amendment 1:1999, Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds. (General Plastic Surgery/General Hospital)
IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (General)
Based on the information from stretcher test results and a review of the predicate device's functions and features, any differences described between the Hill-Rom Procedural Stretcher with Intellidrive® and that of the predicate device do not raise new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the system are the same.
A summary table is included on the following page that compares the new device and the predicate device.
Prepared by: Chad Hodson Senior Regulatory / Quality Engineer Hill-Rom Company
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Food and Drug Administration 10905 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hill-Rom Company % Intertek Testing Services NA, Inc. Ms. Paula Wilkerson 2307 E. Aurora Road / Unit B7 Twinsburg, OH 44087
SEP 1 9 2011
Re: K112502
Trade/Device Name: Hill-Rom® Procedural Stretcher with Intellidrive® Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: II Product Code: INK Dated: September 15, 2011 Received: September 16, 2011
Dear Ms. Wilkerson:
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. 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.
ff 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
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Page 2 - Ms. Paula Wilkerson
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.
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/ucm115809.html 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.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Hill-Rom Company 1069 State Route 46 East Batesville. Indiana 47006
Traditional 510(k) Submis Procedural Stretcher with Intellidrive "
# Indications for Use
510(k) Number (if known): ___ TBD
Device Name: Hill-Rom® Procedural Stretcher with Intellidrive®
Indications for Use:
The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
---
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112502
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.
