(82 days)
The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.
The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
This K021017 document is a 510(k) summary for a medical device called the LeeSpec™ Disposable Vaginal Speculum. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.
Therefore, the "acceptance criteria" for this device are primarily based on its substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the 510(k) summary itself, which highlights the similarities to the predicate device.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
For a 510(k) of this nature, the "acceptance criteria" are not performance metrics in the way one might think of a diagnostic test (e.g., sensitivity, specificity). Instead, they are the criteria for substantial equivalence to the predicate device. The "reported device performance" is the statement that the characteristics of the new device match those criteria.
| Feature (Acceptance Criteria) | ITL LeeSpec™ Disposable Vaginal Speculum (Reported Device Performance) |
|---|---|
| Intended Use: Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. (Meets) |
| Materials of construction: Polystyrene | Polystyrene (Meets) |
| Hand held and manually operated? Yes | Yes (Meets) |
| Design: Dual, biparting blades | Dual, biparting blades (Meets) |
| Single use? Yes | Yes (Meets) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This 510(k) summary does not describe an analytical or clinical study with a "test set" in the traditional sense of evaluating performance metrics. It's a comparison to a predicate device.
- Therefore, there is no sample size for a test set, no data provenance, and no retrospective or prospective study mentioned in this document. The "data" here is the descriptive information of the device and its comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- As there is no traditional "test set" or clinical study, there are no experts mentioned in this document as being used to establish ground truth. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None mentioned, as there was no formal "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a physical speculum and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device and 510(k) submission, the "ground truth" for performance is the established safety and effectiveness of the legally marketed predicate device (Medisul Disposable Vaginal Speculum K000414), which serves as the benchmark against which the new device is compared. The expectation is that because the new device is substantially equivalent in its design, materials, and intended use, it will have similar performance characteristics to the predicate.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an algorithm being developed or a clinical trial in the sense of patient enrollment for a new treatment.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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KO21017
ITL Corporation 03/21/02
JUN 1 9 2002
14 510k Summary
ITL Corporation Submitted by: P.O. Box 139 41-45 Tennant Street Fyshwick ACT 2609 Canberra, Australia
Contact Person: William L. Mobbs, BSc, MBA Director
Date Prepared: March 21, 2002
Proprietary Name: LeeSpec™ Disposable Vaginal Speculum
Common Name: Disposable Vaginal Speculum
Classification Name: Speculum, vaginal, disposable
Predicate Device: Medisul Disposable Vaginal Speculum (K000414)
Description of the Device: The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
Intended Use of the Device: To be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures. For single use only.
Technical Characteristics: The LeeSpec™ Disposable Vaginal Speculum is made of high impact polystyrene with dual biparting blades. It is manually operated and has a locking (open) and unlocking (release) features, which can be adjusted with one hand. The LeeSpec™ Disposable Vaginal Speculum has the same technological characteristics as and is substantially equivalent to the Medisul disposable Vaginal Speculum (K000414), as shown in the following table:
| Feature | ITL LeeSpec™ Disposable Vaginal Speculum | Medisul Disposable Vaginal Speculum (K000414) |
|---|---|---|
| Intended Use | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. |
| Materials of construction | Polystyrene | Polystyrene |
| Hand held and manually operated? | Yes | Yes |
| Design | Dual, biparting blades | Dual, biparting blades |
| Single use? | Yes | Yes |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
·
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2002
Received: March 29, 2002
Mr. William L. Mobbs Director ITL Corporation 41-45 Tennant Street, Fyshwick Canberra, ACT 2609 AUSTRALIA
Re: K021017 Trade/Device Name: LeeSpec™ Disposable Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: March 25, 2002
Dear Mr. Mobbs:
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 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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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket 510k Notification LeeSpecTM Disposable Vaginal Speculum
Exhibit L ITL Corporation
Page of
510k Number: _ Kのマノロ/ス
Device Name: LeeSpec™ Disposable Vaginal Speculum
Indications For Use:
The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.
Prescription Use
David A. Syverson
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.