(11 days)
KleenSpec® Single Use Vaginal Speculum
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The vaginal speculum can be used with or without the illuminator.
KleenSpec® 790 Series Cordless Illuminator
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
The illuminator can be used independent of the speculum as a general-purpose light source.
This product is available for sale only upon the order of a physician or licensed health care professional.
The subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data.
Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.
The provided text is a 510(k) Summary for a medical device: the KleenSpec® Single Use Vaginal Speculum. It describes a modification to an existing device (the addition of an extra small size) and explicitly states that no clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data.
Therefore, the device's acceptance criteria are not based on clinical performance metrics, but rather on its substantial equivalence to a predicate device. The study that proves the device meets acceptance criteria is non-clinical bench testing and adherence to design control procedures.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to predicate device (K070964) in terms of safety and efficacy. | Demonstrated substantial equivalence through bench test data. |
| Same technological characteristics and indications for use as the predicate device. | Confirmed to have the same characteristics and indications for use. |
| Materials used for the new size speculum are the same as previously cleared speculums. | Stated that the new size and previously cleared speculums are made of the same materials. |
| Biocompatibility testing according to FDA Blue Book Memo, G95-1 (ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device). | Materials have undergone biocompatibility testing and are demonstrated to be suitable for intended use. |
| Performance parameters conform to product design specifications. | Verification and validation tests conducted to ensure performance parameters conform to design specifications. |
| Application of risk management (ISO 14971). | ISO 14971 was applied to the modified device. |
| No new concerns regarding safety or efficacy introduced by the extra small size. | Stated that the addition of the extra small size does not introduce any new concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (N/A) – No clinical test set was used. The evaluation was based on non-clinical bench testing.
- Data provenance: Not applicable (N/A) – No clinical data (from a country of origin, retrospective or prospective) was used. Testing was conducted internally by Welch Allyn.
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)
- Not applicable (N/A) – No clinical test set requiring expert ground truth was utilized. The assessment was based on engineering design validation and verification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A) – No clinical test set requiring adjudication was utilized.
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
- Not applicable (N/A) – This device is a physical medical instrument (vaginal speculum), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A) – This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (N/A) – No clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for this regulatory submission was established through engineering design specifications, material specifications, and performance testing against those specifications, implicitly confirming the device's functional integrity and safety characteristics are equivalent to the predicate.
8. The sample size for the training set
- Not applicable (N/A) – No training set was used. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable (N/A) – No training set or associated ground truth was established for this device.
§ 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.