(88 days)
Not Found
No
The 510(k) summary describes a convenience kit of standard, disposable medical devices for obstetrical and gynecological procedures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: The device is described as a "convenience assemblage of sterile, disposable medical devices" used for various gynecological and obstetrical procedures, with examples like "Vaginal Delivery Pack" and "C Section Pack." It does not inherently perform any therapeutic action itself but rather contains devices used by physicians during procedures. The description indicates it's a kit of medical devices, not a therapeutic device.
No
Explanation: The document describes the device as "convenience assemblage of sterile, disposable medical devices" and "custom Ob/Gyn procedure trays or kits" intended for various gynecological and obstetrical procedures. There is no mention of the device being used to diagnose conditions, only to facilitate procedures.
No
The device description explicitly states it is a "convenience assemblage of sterile, disposable medical devices" and "sterile, disposable, medical device convenience kits," indicating it is a collection of physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the kits are for "various gynocological and obstetrical procedures" performed by trained physicians. This describes a surgical or procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The description refers to the kits as "sterile, disposable, medical device convenience kits" containing various medical devices. This aligns with surgical or procedural kits, not diagnostic reagents or instruments used for testing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the information provided strongly indicates that this device is a collection of medical devices for surgical/procedural use, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices".
NHMC does not cause or promote new intended uses for the devices within these kits.
Product codes
85 KNA
Device Description
The NHMC custom Ob/Gyn procedure trays or kits are sterile, disposable, medical device convenience kits. NHMC currently markets these kit in Canada as Vaginal Delivery Pack, C Section Pack, and others. These kits are custom to the customer, whose specifies the type and quantity of the materials to be included in the kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization was process used in the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
- The labeling, packaging and method of sterilization of the suture cannot be changed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.
§ 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.
0
AUG 26 1997
Attachment 1 510(k) Summary
11072
National Healthcare Manufacturing Corp. Ob/Gyn Kit or Tray
Submitter Information:
Alice Gibson General Manager National Healthcare Manufacturing Corp. 251 Sulteaux Crescent Winnipeg, Manitoba R3J 3C7 Canada
510(k) Summary Prepared by:
Carolann Kotula Official Correspondent for NHMC c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared: May 8, 1997
Name/Classification of the Device:
Classification Name:
Labor and Delivery Tray
Common Name:
Ob/Gyn Procedure Pack, Tray, or Kit
1
| Proprietary Name: | National Healthcare Manufacturing
Corp. custom Ob/Gyn kits or trays |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | A classification for these devices
could not be located, however, the
medical devices within the kits or trays
are Class I and Class II devices |
Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: Custom medical convienance kits or trays are are a commonly available to medical professionals and institutions. Baxter received marketing clearance for a "D & C Tray" under K901442. Medical Device Inspection Co., Inc. received approval to market a C-Section Tray Under K912017/B.
Comparative Information: The subject device and the predicates are substantially identical in materials, packaging, sterilization and intended use.
Description of the Subject Device: The NHMC custom Ob/Gyn procedure trays or kits are sterile , disposable , medical device convenience kits. NHMC currently markets these kit in Canada as Vaginal Delivery Pack, C Section Pack, and others. These kits are custom to the customer, whose specifies the type and quantity of the materials to be included in the kit.
Intended Use of the Subject Device: These kits are a convenience assemblage of medical devices intended for use by trained physicians for obstetrical and gynocological procedures. National Healthcare Manufacturing Corporation does not cause or promote new intended uses for the devices within these kits.
Technological Characteristics of the Subject Device: There are no differences in the characteristics of the subject device and the predicate.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head in profile, with three wing-like shapes extending from the back of the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
National Healthcare Manufacturing Corporation c/o Ms. Carolann Kotula 1. 1. 1. 1. Vice President, RA/QA mdi Consultants, Inc. 55 Northern Boulevard Great Neck, New York, 11021
Re: K972013 National Medical Healthcare custom Ob/Gyn kits, trays, or packs Dated: May 28, 1997 Received: May 30, 1997 Regulatory class: II 21 CFR §884.4530/Product code: 85 KNA
AUG 26 1997
Dear Ms. Kotula:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You may, therefore, market the device, subject to the general controls (Act). provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit/tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please If you purchase your device components in bulk (i.e., unfinished) and note: further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗೆ substancially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Carolann Kotula
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization was process used in the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
- The labeling, packaging and method of sterilization of the suture cannot 1. be changed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be changed 2. without prior notification, review and clearance by FDA.
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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Robert R. Ratliff/
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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Attachment 3, revised 8/13/97 page __ of 2
510(k) Number (if known): K972013
Device Name: NHMC Custom Ob/Gyn Pack
Indications. for. Use: ... . . . . . . . .
This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices".
NHMC does not cause or promote new intended uses for the devices within these kits.
x
(Please Do Not Write Below this Line/Continue on Another Page ii Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE )
Robert R. Anthony/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
OR
Prescription Use
(per 21 CFR 801.109)
Over the Counter Use _
(Optional Format 1-2-96)
5
ದಿನ
K972013 NHMC Custom Ob/Gyn Pack Indications for Use Page 2 of 2
Obstetrical and Gynecological Convenience Kits or Packs
Amniocentesis Tray Breast Pump Kit Cervical Smear Kit Cesarean Section Tray Circumcision Tray Culdocentesis Kit Cytology Kit D and C Tray Delivery Kit Emergency Obstetrical Kit Endometrial Sampling Kit Fetal Blood Sampling Kit (Excludes HIV testing) Forensic Evidence Sexual Assault Kit Gynecological Laparoscopic Kit Labor and Delivery Kit Maternity Kit Obstetrical Kit Obstetrical Anesthesia Kit Obstetrical Vacuum Delivery Kit Pap Smear Kit Paracervical Anesthesia Kit Seminal Fluid Collection Kit Trocar Kit Vaginal Examination Tray Vasovasostomy Set
Robert D. Ratliff/
(Division Sign-Off) Civision of Reproductive, Abdominal, ENT, of Padioingical Devices 1972013 10(k) Number _
/
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use