(120 days)
Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual filud: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.
Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.
This 510(k) summary (K971979) describes the substantial equivalence of new Playtex tampons to previously cleared Playtex tampons, rather than presenting a study to prove a device meets specific acceptance criteria in the way a diagnostic or therapeutic medical device might. The document focuses on showing that the new tampons have the same technological characteristics and intended use as the predicate devices, and that nonclinical testing supports their safety.
Therefore, many of the requested categories (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly met through the demonstration of substantial equivalence to predicate devices, particularly regarding safety aspects. Performance is considered equivalent to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: No significant differences in safety profiles compared to predicate devices. | Nonclinical Testing Referenced: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing all suggest equivalent safety to predicate devices. The new tampon has the same technological characteristics (fiber, string, materials in contact with vaginal wall) or same mode of action. |
| Effectiveness/Intended Use: Absorption of menstrual fluid, consistent with predicate devices. | Intended Use: "Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid," which is identical to the stated use of the predicate device. |
| Substantial Equivalence: To previously cleared Playtex tampons (Gentle Glide®, Silk Glide®, Slimfits™, Soft Comfort™ and Portables® Tampons, Regular, Super and Super Plus). | The document explicitly states: "The new Playtex tampons are substantially equivalent to previously cleared Playtex Gentle Glide®, Silk Glide®, Slimfits™, Soft Comfort™ and Portables® Tampons, Regular, Super and Super Plus." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any "test set" in the context of device performance characteristics like accuracy or sensitivity. The nonclinical tests listed (e.g., human sensitization, animal toxicity) would have their own sample sizes but these are not detailed in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document refers to "Nonclinical testing," which typically means laboratory and/or animal studies, and potentially human volunteer studies for sensitization/irritation. The context suggests these are likely prospective studies conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable (N/A): This type of medical device (tampons) does not typically involve expert readers or establishing "ground truth" through consensus in the way image analysis or diagnostic devices do. The testing referenced is primarily physical, chemical, and biological safety testing.
4. Adjudication Method for the Test Set
- Not applicable (N/A): As there's no "test set" requiring expert evaluation or ground truth adjudication in the conventional sense, no adjudication method is mentioned.
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 menstrual tampon and does not involve AI or human readers for comparative effectiveness studies in the diagnostic sense.
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 product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" here is established primarily through laboratory testing results (e.g., in-vitro toxicology, in-vivo irritation, TSST-1 production) and industry standards/benchmarks for tampons, demonstrating that the materials and design are safe and function effectively for menstrual fluid absorption. The "truth" is that the new tampon performs as safely and effectively as existing, legally marketed tampons.
8. The Sample Size for the Training Set
- Not applicable (N/A): This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable (N/A): As there is no training set, this is not relevant.
§ 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.