(86 days)
The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.
The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.
The provided text describes a medical device called "Glo-Spec I, II and III," which are connectors for medical devices, primarily used for transmitting light and holding suction tubes and instruments. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested elements for a rigorous device performance study are not explicitly stated or applicable in this 510(k) summary. The document does not describe a performance study with numerical acceptance criteria and results in the way a clinical trial might. Instead, it relies on a comparison to a predicate device.
Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating when information is not provided.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of numerical acceptance criteria. Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to a predicate device, the Welch Allyn Kleenspec, and other devices. The "performance" is summarized as being "constructurally equivalent" and complying with "all acceptance criteria listed above" (referring to the characteristics listed under "Physical/Technical Comparison").
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Glo-Spec I, II and III) |
|---|---|
| Same intended use of transmitting light, hold suction tubes and instruments | Yes, meets this. |
| Manufactured through injection molding | Yes, made of injected molded parts. |
| Made with same materials | Yes, made with same materials. |
| Maintain same rigidity of part | Yes, maintains same rigidity. |
| Both have clear plastic | Yes, has clear plastic. |
| Both have windows that allow heat to escape | Yes, has vents to allow heat to escape. |
| Does not alter the utilization, safety or efficacy of the predicate device (when afforded light for visualization) | Yes, "Does not alter the utilization, safety or efficacy of the Nu-Spec D while affording light for visualization." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission relies on a comparison to "millions of applications" of predicate devices, implying a general understanding of the predicate's performance rather than a specific test set for the Glo-Spec.
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)
This information is not provided. As no specific test set or clinical study is detailed, the concept of expert-established ground truth for a test set is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no described test set or adjudication process.
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
An MRMC study was not done. This device is a passive connector, not an AI-assisted diagnostic tool or an imaging device for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done or described. This device is a physical connector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic device studies is not applicable here. The performance is assessed based on functional equivalence to predicate devices, which are assumed to be safe and effective based on their established market history ("millions of applications").
8. The sample size for the training set
This information is not provided. There is no training set mentioned as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not provided. As there is no training set, this is not applicable.
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K020959
1043
JUN 1 9 2002
03/18/02 Page 7a
| 10. | 510(k) Summary | |
|---|---|---|
| Date | March 18, 2002 | |
| Manufacturer: | Not applicable at time of submission. EstablishedRegistration will be submitted upon determination ofmanufacturer | |
| Owner: | Sol Weiss, M.D.7012 Reseda BoulevardSuite AReseda, California 91335 | |
| Contact Person: | Sol Weiss, M.D. | |
| Device Trade Name: | Glo- Spec I, II and III | |
| Common Name: | Connectors | |
| Classification Name: | Connector for devices (accessory to #12859 and othermanufacturers) | |
| Regulatory Reference: | 884.4530(17) |
Description:
- The devices are made of injected molded parts .
- Does not require assembly (simple product) .
- Has vents to allow heat to escape .
- No contact with body surfaces .
- Has interlocking cone for device attachment .
- The device is for single use only .
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K020959
2g3
03/18/02 Page 7b
510(k) Summary
Intended use:
- The intended use is interconnection of devices for transmission of light, ● hold suction tubes and instruments for other manufacturers
- The intended use is to illuminate area of view .
Physical / Technical Comparison:
- Have the same intended use of transmitting light, hold suction tubes and ● instruments of other manufacturers
- Manufactured through injection molding ●
- Made with same materials ●
- Maintain same rigidity of part �
- Both have clear plastic �
- Both have windows that allow heat to escape .
Differences:
- Attaches to upper blades of speculums and retractors to keep viewing . clear
- Rests in the upper blades of Nu-Spec D and other manufacturer's . speculums and retractors
- Does not alter the utilization, safety or efficacy of the Nu-Spec D while ● affording light for visualization
- · Glo-Spec I, II and III portable connector has no body or membrane contact. Kleenspec connector as part of the handle has contact with the body surface.
- Glo-Spec I, II and III portable connector will allow for other different light . sources to be used (i.e. penlights, etc.) Welch Allyn's Kleenspec only permits their transformer and equipment as a light source.
- Glo-Spec I, II and III portable connector place is above and out of area . where bleeding may contaminate this device
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Ko20959
3073 03/18/02 Page 7c
Performance Summary:
- . Constructurally equivalent to the Welch Allyn's Kleenspec, and other predicate devices which have already been subjected to millions of applications
The Glo-Spec I, II and III complies with all acceptance criteria listed above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2002
Sol Weiss. M.D. Sol Weiss, M.D., Inc. 7012 Reseda Boulevard, Suite A RESEDA CA 91335
Re: K020959
Trade/Device Name: Glo-Spec I, II, and III Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument
Regulatory Class: II Product Code: 85 HIB Dated: March 18, 2002 Received: March 25, 2002
Dear Dr. Weiss:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/12 description: The image shows a partial view of a seal or emblem. The text "DEPARTMENT OF HEALTH &" is visible, arranged in a curved manner, suggesting it forms part of a circular design. The rest of the image is obscured, but it appears to contain some stylized graphic elements, possibly part of a larger symbol or crest associated with the Department of Health. The image is in black and white.
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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/dsma/dsmamain.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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510(k) Number (if known): KO20959
Device Name: __ Glo-Spec™ I, II and III
Indications for use:
The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Bergman
Division Sian-Of sion of Reproduc Radiological Devic
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.