The Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
Device Story
Brella-Spec™ Vaginal Speculum is a sterile, single-use, non-metal device designed for gynecological and obstetrical examinations. It features a triple-blade design (one stationary, two articulating) operated by a manual ratchet mechanism to provide an adjustable view window (5.8-31 cm²). The device incorporates a fully enclosed LED illumination system to light the field of view. Used in clinical settings by medical professionals, the speculum provides visualization and exposure of the vaginal interior. The device is constructed from biocompatible polypropylene and acrylic polycarbonate. It is provided sterile in a PETG tray with a Tyvek lid. The device benefits patients by providing improved visualization and access during procedures compared to traditional specula.
Clinical Evidence
No clinical studies were conducted. Evidence is based on bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11137), packaging validation (ISO 11607), and electrical safety (IEC 60601-1).
Technological Characteristics
Materials: Polypropylene and acrylic polycarbonate. Design: Triple-blade (1 stationary, 2 articulating) with manual ratchet. Illumination: Integrated LED system. Sterilization: Radiation (ISO 11137). Packaging: Sterile PETG tray with Tyvek lid. Electrical safety: IEC 60601-1 compliant.
Indications for Use
Indicated for visualization and exposure of the vagina by medical professionals during gynecological and obstetrical procedures and examinations.
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.
Predicate Devices
Depalt Vaginal Speculum 2000 Series and Depalt Lighting System (K072762)
Submission Summary (Full Text)
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APR 2 8 2014
510(k) Summary
Applicant: Proa Medical, Inc. . 2512 Artesia Blvd. Suite 305C Redondo Beach, CA 90278-3269 United States Contact: Victoria Nadershahi 1-800-899-3385 victoria@proamedical.com
| Date Summary Prepared: | April 24th, 2014 |
|------------------------|---------------------------------------------|
| Trade Name: | Brella-SpecTM Vaginal Speculum |
| Common or Usual Name: | Speculum, Vaginal, Nonmetal |
| Device Class: | Class II |
| Classification Code: | HIB |
| Classification Name: | 21 CFR 884.4530 Speculum, Vaginal, Nonmetal |
## Device Intended Use
The Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.
Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
## Device Indications for use
·
The Brella-Spec"M Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.
Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the ficid during procedures and examinations.
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## Predicate Device
- Depalt Vaginal Speculum 2000 Series and Depalt Lighting System cleared for marketing under a) 510(k) notification number K072762.
## Device Description
The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.
#### Technological Characteristics
The Brella-Spec™ Vaginal Speculum has substantially equivalent technological characteristics and the same indications for use as the predicate device Depalt Vaginal Speculum 2000 Series and Depalt Lighting System. The use of polypropylene and acrylic polycarbonate along with providing the device in sterile PETG tray and Tyvek lid does not introduce any new concerns regarding safety or effectiveness. The design has been demonstrated as substantially equivalent using bench test data.
## Performance Data
The Brclla-Spec™ Vaginal Speculum has been tested for biocompatibility in accordance with the Food and Drug Administration Blue Book Memo, G95-1, use of international standard ISO-10993 Requirements for limited contact duration, surface contacting, breached mucosal membrane device and are demonstrated to be suitable for the intended use of this product. The sterilization method for the Brella-Spec™ Vaginal Speculum has been validated and tested in accordance with ISO 11137: -Sterilization of healthcare products-Radiation. The packaging for the Brella-Spec"M Vaginal Speculum has been validated and tested in accordance with ISO 11607-Packaging for terminally sterile medical devices. In addition, the Brolla-Speculum has been tested for electrically safety in accordance with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Verification and validation tests were conducted in accordance with Proa Medical, Inc., design control procedures. The Brella-Speculum was tested using established testing procedures to ensure the performance parameters conform to the product design specifications. ISO 14971- Medical Devices-Application of Risk Management to medical devices was followed to mitigate risks that may be. associated with the device.
No clinical studies have been done for the purpose of obtaining safety and effectiveness data.
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# Substantial Equivalence
The Brella-Spec™ Vaginal Speculum has substantially equivalent technological characteristics and the same indications for use as the predicate Depart Vaginal Speculum 510(k) K072762. The differences in the design features do not have an impact on safety and effectiveness of the subject device.
| Parameter | Subject device (K133857) | Predicate device (K072762) | Differences |
|------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Brella-Spec™ Vaginal<br>Speculum | Depalt Vaginal Speculum and<br>Depalt Lighting System | |
| Indications for<br>Use | Same as the predicate | Used for the purposes of<br>visualization and exposure of the<br>interior of the vagina by a<br>medical professional during<br>gynecological and obstetrical<br>procedures/ examinations.<br>Depalt Lighting System provides<br>the light necessary to illuminate<br>the field during<br>procedures/examinations." | |
| Dimension | · Blade (stationary)<br>length 4.5"<br>· Blade (stationary) width<br>1.2"<br>· Handle length 2.5" | · Blade length 4.4"<br>· Blade width 1.1"<br>· Handle length 3" | The difference is minimal;<br>no safety or effectiveness<br>concerns |
| Blade | Triple blades (1 stationary,<br>2 articulating) | Dual blades (1 stationary, 1<br>articulating) | The difference does not have<br>an impact on safety of the<br>subject device. With two<br>articulating blades, the<br>subject device should be<br>more effective because it<br>provides larger vagina-<br>contacting surface and view<br>window. |
| Blade<br>movement | 2 articulating blades move<br>horizontally | 1 articulating blade moves<br>vertically | The difference does not<br>influence safety of subject<br>device. The subject device<br>should be more effective<br>because it provides larger<br>view window with two<br>articulating blades. |
| Hinge | Same as the predicate | 2-hinge system | |
| Thumb paddle | 1 on left side, 1 on right<br>side | 1 on back side | The difference does not<br>cause any safety and<br>effectiveness concerns.<br>Actually the subject device<br>should have better control<br>with two thumb paddles |
| Ratchet teeth | Similar to the predicate | Vertical ratchet teeth | |
| View window | Adjustable area (5.8-31<br>cm²) | Fixed area (18 cm²) | The difference makes the<br>subject device more flexible<br>and effective without safety<br>concerns |
| Illumination<br>system | Same as the predicate | Built-in LED light with battery | |
| Materials | Polypropylene and Acrylic<br>Polycarbonate | Polystyrene | The subject and predicate<br>devices are different in<br>materials. However, a full<br>battery of biocompatibility<br>testing was conducted on the<br>subject device to ensure<br>safety |
| Sterility | Sterile | Non-sterile | The subject device is<br>provided sterile whereas the<br>predicate device is not. The<br>difference makes the subject<br>device safer |
| Use life | Same as the predicate | Single-use, disposable | |
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K133857 Page 4 of 4
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2014
Proa Medical, Inc. Victoria Nadershahi RA/OA Manager 2512 Artesia Blvd. Suite 305C Redondo Beach, CA 90278
Re: K133857
> Trade/Device Name: Brella-Spec Vaginal Speculum Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: March 26, 2014 Received: March 27, 2014
Dear Victoria Nadershahi,
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.
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.
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Page 2 -- Victoria Nadershahi
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.
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.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/ReportalProblem/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,
Benjamin R Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.
510(k) Number (if known)
K133857
Device Name
Brella-Spec Vaginal Speculum
Indications for Use (Describe)
Brella-Spec Vaginal Speculum is used for visualization and exposure of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.
Brella-Spec Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
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)
## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
( ) = = = = = = = FOR EDA USE ONLY = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| Benjamin R. Fisher S. |
|----------------------------|
| 2014.04.28 14:54:22+04'00' |
FORM FDA 3881 (1/14)
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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.
